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1. Urinary uromodulin independently predicts end-stage renal disease and rapid kidney function decline in a cohort of chronic kidney disease patients.

Author

Steubl D, Block M, Herbst V, Nockher WA, Schlumberger W, Kemmner S, Bachmann Q, Angermann S, Wen M, Heemann U, Renders L, Garimella PS, and Scherberich J

Subjects
Adult, Aged, Area Under Curve, Cohort Studies, Disease Progression, Female, Glomerular Filtration Rate, Humans, Kidney physiopathology, Kidney Function Tests methods, Male, Middle Aged, Multivariate Analysis, Predictive Value of Tests, Proportional Hazards Models, ROC Curve, Renal Insufficiency, Chronic complications, Risk Factors, Kidney Failure, Chronic etiology, Kidney Function Tests statistics & numerical data, Proteinuria etiology, Renal Insufficiency, Chronic urine, Uromodulin urine
Abstract

Data on risk factors predicting rapid progression to end-stage renal disease (ESRD) or short-term kidney function decline (i.e., within 1 year) in chronic kidney disease (CKD) are rare but urgently needed to plan treatment. This study describes the association and predictive value of urinary uromodulin (uUMOD) for rapid progression of CKD.We assessed uUMOD, demographic/treatment parameters, estimated glomerular filtration rate (eGFR), and proteinuria in 230 CKD patients stage I-V. ESRD and 25% decline of eGFR was documented at the end of follow-up period and used as a composite endpoint. Association between logarithmic uUMOD and eGFR/proteinuria was calculated using linear regression analysis, adjusting for age, gender, and body mass index. We performed multivariable Cox proportional hazard regression analysis to evaluate the association of uUMOD with the composite endpoint. Therefore, patients were categorized into quartiles. The predictive value of uUMOD for the above outcomes was assessed using receiver-operating characteristic (ROC) curve analysis.Follow-up was 57.3 ± 18.7 weeks, baseline age was 60 (18;92) years, and eGFR was 38 (6;156) mL/min/1.73 m. Forty-seven (20.4%) patients reached the composite endpoint. uUMOD concentrations were directly associated with eGFR and inversely associated with proteinuria (β = 0.554 and β = -0.429, P < .001). In multivariable Cox regression analysis, the first 2 quartiles of uUMOD concentrations had a hazard ratio (HR) of 3.589 [95% confidence interval (95% CI) 1.002-12.992] and 5.409 (95% CI 1.444-20.269), respectively, in comparison to patients of the highest quartile (≥11.45 μg/mL) for the composite endpoint. In ROC-analysis, uUMOD predicted the composite endpoint with good sensitivity (74.6%) and specificity (76.6%) at an optimal cut-off at 3.5 μg/mL and area under the curve of 0.786 (95% CI 0.712-0.860, P < .001).uUMOD was independently associated with ESRD/rapid loss of eGFR. It might serve as a robust predictor of rapid kidney function decline and help to better schedule arrangements for future treatment.

Published
2019
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2. Comparison of 24-hour and Office Pulse Wave Velocity for Prediction of Mortality in Hemodialysis Patients.

Author

Matschkal J, Mayer CC, Sarafidis PA, Lorenz G, Braunisch MC, Guenthner R, Angermann S, Steubl D, Kemmner S, Bachmann Q, Hauser C, Nerl L, Baumann M, Mann JF, Moog P, Kuechle C, Renders L, Heemann U, Wassertheurer S, and Schmaderer C

Subjects
Aged, Female, Follow-Up Studies, Humans, Kaplan-Meier Estimate, Kidney Failure, Chronic therapy, Longitudinal Studies, Male, Middle Aged, Office Visits, Predictive Value of Tests, Prognosis, Prospective Studies, Risk Assessment methods, Risk Factors, Blood Pressure Monitoring, Ambulatory methods, Kidney Failure, Chronic mortality, Pulse Wave Analysis methods, Renal Dialysis
Abstract

Background: Mortality in hemodialysis patients still remains unacceptably high. Enhanced arterial stiffness is a known cardiovascular risk factor, and pulse wave velocity (PWV) has proven to be a valid parameter to quantify risk. Recent studies showed controversial results regarding the prognostic significance of PWV for mortality in hemodialysis patients, which may be due to methodological issues, such as assessment of PWV in the office setting (Office-PWV)., Method: This study cohort contains patients from the "Risk stratification in end-stage renal disease - the ISAR study," a multicenter prospective longitudinal observatory cohort study. We examined and compared the predictive value of ambulatory 24-hour PWV (24 h-PWV) and Office-PWV on mortality in a total of 344 hemodialysis patients. The endpoints of the study were all-cause and cardiovascular mortality. Survival analysis included Kaplan-Meier estimates and Cox regression analysis., Results: During a follow-up of 36 months, a total of 89 patients died, 35 patients due to cardiovascular cause. Kaplan-Meier estimates for tertiles of 24 h-PWV and Office-PWV were similarly associated with mortality. In univariate Cox regression analysis, 24 h-PWV and Office-PWV were equivalent predictors for all-cause and cardiovascular mortality. After adjustment for common risk factors, only 24 h-PWV remained solely predictive for all-cause mortality (hazard ratio 2.51 [95% CI 1.31-4.81]; p = 0.004)., Conclusions: Comparing both measurements, 24 h-PWV is an independent predictor for all-cause-mortality in hemodialysis patients beyond Office-PWV., (© 2019 S. Karger AG, Basel.)

Published
2019
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3. Mortality prediction in stable hemodialysis patients is refined by YKL-40, a 40-kDa glycoprotein associated with inflammation.

Author

Lorenz G, Schmalenberg M, Kemmner S, Haller B, Steubl D, Pham D, Schreiegg A, Bachmann Q, Schmidt A, Haderer S, Huber M, Angermann S, Günthner R, Braunisch M, Hauser C, Reichelt AL, Matschkal J, Suttmann Y, Moog P, Stock K, Küchle C, Thürmel K, Renders L, Bauer A, Baumann M, Heemann U, Luppa PB, and Schmaderer C

Subjects
Aged, Biomarkers blood, Cross-Sectional Studies, Female, Humans, Kidney Failure, Chronic blood, Kidney Failure, Chronic diagnosis, Male, Middle Aged, Predictive Value of Tests, Renal Dialysis adverse effects, Retrospective Studies, Risk Assessment, Risk Factors, Time Factors, Treatment Outcome, Chitinase-3-Like Protein 1 blood, Inflammation Mediators blood, Kidney Failure, Chronic mortality, Kidney Failure, Chronic therapy, Renal Dialysis mortality
Abstract

Chronic inflammation contributes to increased mortality in hemodialysis (HD) patients. YKL-40 is a novel marker of inflammation, tissue remodeling, and highly expressed in macrophages inside vascular lesions. Elevated levels of YKL-40 have been reported for HD patients but how it integrates into the proinflammatory mediator network as a predictor of mortality remains elusive. We studied serum YKL-40, Interleukin-6 (IL-6), high-sensitivity C-reactive protein, monocyte chemotactic protein-1 (MCP-1), and interferon-gamma induced protein-10 (IP-10) in 475 chronic hemodialysis patients. Patients were followed for mortality for a median of 37 [interquartile range: 25-49] months and checked for interrelation of the measured mediators. To plot cumulative incidence functions, patients were stratified into terciles per YKL-40, IL-6, MCP-1, and IP-10 levels. Multivariable Cox regression models were built to examine associations of YKL-40, IP-10, and MCP-1 with all-cause and cause-specific mortality. Net reclassification improvement was calculated for the final models containing YKL-40 and IL-6. Increased YKL-40 was independently associated with age, IP-10, and IL-6 serum levels. After adjustment for demographic and laboratory parameters, comorbidities, and IL-6, only YKL-40 significantly improved risk prediction for all-cause (hazard ratio 1.4; 95% confidence interval 1.1-1.8) and cardiovascular mortality (hazard ratio 1.5; 95% confidence interval 1.03-2.2). Thus, in contrast to other biomarkers of aberrant macrophage activation, YKL-40 reflects inflammatory activity, which is not covered by IL-6. Mechanistic and prospective studies are needed to test for causal involvement of YKL-40 and whether it might qualify as a therapeutic target., (Copyright © 2017 International Society of Nephrology. Published by Elsevier Inc. All rights reserved.)

Published
2018
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4. Unacceptable human leucocyte antigens for organ offers in the era of organ shortage: influence on waiting time before kidney transplantation.

Author

Ziemann M, Heßler N, König IR, Lachmann N, Dick A, Ditt V, Budde K, Reinke P, Eisenberger U, Suwelack B, Klein T, Westhoff TH, Arns W, Ivens K, Habicht A, Renders L, Stippel D, Bös D, Sommer F, Görg S, Nitschke M, Feldkamp T, Heinemann FM, and Kelsch R

Subjects
Adult, Aged, Female, Histocompatibility Testing, Humans, Male, Middle Aged, Retrospective Studies, Transplantation, Homologous, HLA Antigens immunology, Kidney immunology, Kidney Failure, Chronic surgery, Kidney Transplantation statistics & numerical data, Tissue Donors, Tissue and Organ Procurement methods, Waiting Lists
Abstract

Background: The assignment of human leucocyte antigens (HLAs) against which antibodies are detected as unacceptable antigens (UAGs) avoids allocation of HLA- incompatible allografts. There is uncertainty as to what extent UAGs decrease the probability of receiving a kidney offer., Methods: Kidney transplantations in 3264 patients on the waiting lists of six German transplant centres were evaluated for a period of at least 2 years. The proportion of excluded offers due to UAGs was calculated as virtual panel-reactive antibodies (vPRAs)., Results: In the common Eurotransplant Kidney Allocation Scheme, the transplant probability was unaffected by vPRAs in exploratory univariate analyses. In the multivariable model, a 1% increase in vPRA values was outweighed by an additional waiting time of 2.5 weeks. The model was confirmed using an external validation cohort of 1521 patients from seven centres. If only patients with standard risk were considered (e.g. no simultaneous transplantation of other organs), only 1.3 weeks additional waiting time was needed. In the Eurotransplant Senior Program, patients with vPRA values >50% had a strongly reduced transplant probability in the unadjusted analyses. In the multivariable model, a 1% increase in vPRA values was outweighed by an additional waiting time of 5 weeks., Conclusions: This study demonstrates that the assignment of UAGs decreases the transplant probability in both main Eurotransplant allocation programs because of insufficient compensatory mechanisms. At present, for immunized patients, a prolonged waiting time has to be weighed against the increased immunologic risk due to donor-specific antibodies not assigned as UAGs., (© The Author 2017. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.)

Published
2017
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5. Rationale and study design of the prospective, longitudinal, observational cohort study "rISk strAtification in end-stage renal disease" (ISAR) study.

Author

Schmaderer C, Tholen S, Hasenau AL, Hauser C, Suttmann Y, Wassertheurer S, Mayer CC, Bauer A, Rizas KD, Kemmner S, Kotliar K, Haller B, Mann J, Renders L, Heemann U, and Baumann M

Subjects
Cardiovascular Diseases mortality, Cardiovascular Diseases physiopathology, Cause of Death, Electrocardiography, Gastrointestinal Diseases mortality, Hospitalization statistics & numerical data, Humans, Infections mortality, Kidney Failure, Chronic physiopathology, Kidney Failure, Chronic therapy, Longitudinal Studies, Lung Diseases mortality, Neuropsychological Tests, Phenotype, Prospective Studies, Pulse Wave Analysis, Renal Dialysis, Retinal Vessels diagnostic imaging, Risk Assessment, Wounds and Injuries mortality, Cardiovascular Diseases complications, Kidney Failure, Chronic complications, Neoplasms mortality, Research Design
Abstract

Background: The ISAR study is a prospective, longitudinal, observational cohort study to improve the cardiovascular risk stratification in endstage renal disease (ESRD). The major goal is to characterize the cardiovascular phenotype of the study subjects, namely alterations in micro- and macrocirculation and to determine autonomic function., Methods/design: We intend to recruit 500 prevalent dialysis patients in 17 centers in Munich and the surrounding area. Baseline examinations include: (1) biochemistry, (2) 24-h Holter Electrocardiography (ECG) recordings, (3) 24-h ambulatory blood pressure measurement (ABPM), (4) 24 h pulse wave analysis (PWA) and pulse wave velocity (PWV), (5) retinal vessel analysis (RVA) and (6) neurocognitive testing. After 24 months biochemistry and determination of single PWA, single PWV and neurocognitive testing are repeated. Patients will be followed up to 6 years for (1) hospitalizations, (2) cardiovascular and (3) non-cardiovascular events and (4) cardiovascular and (5) all-cause mortality., Discussion/conclusion: We aim to create a complex dataset to answer questions about the insufficiently understood pathophysiology leading to excessively high cardiovascular and non-cardiovascular mortality in dialysis patients. Finally we hope to improve cardiovascular risk stratification in comparison to the use of classical and non-classical (dialysis-associated) risk factors and other models of risk stratification in ESRD patients by building a multivariable Cox-Regression model using a combination of the parameters measured in the study., Clinical Trials Identifier: ClinicalTrials.gov NCT01152892 (June 28, 2010).

Published
2016
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6. Allocation strategies for elderly kidney transplant recipients.

Author

Heemann U and Renders L

Subjects
Aged, Humans, Kidney Failure, Chronic epidemiology, Patient Selection, Tissue Donors statistics & numerical data, Waiting Lists, Health Services Accessibility, Kidney Failure, Chronic surgery, Kidney Transplantation statistics & numerical data, Tissue Donors supply & distribution, Tissue and Organ Procurement
Abstract

In all modern societies, the percentage of elderly people is increasing. However, this does not necessary reflect the percentage of patients waiting for a new kidney and the availability of organs for this entity differs markedly between countries. Thus, allocation strategies for elderly kidney recipients should be based on the characteristics of the specific countries and take into account: access to the waiting list and availability of living as well as marginal and conventional post-mortem donors., (Copyright © 2015. Published by Elsevier Inc.)

Published
2015
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7. C-terminal agrin fragment (CAF) as a serum biomarker for residual renal function in peritoneal dialysis patients.

Author

Steubl D, Hettwer S, Dahinden P, Luppa P, Rondak IC, Regenbogen C, Stock KF, Renders L, Heemann U, and Roos M

Subjects
Adult, Aged, Aged, 80 and over, Agrin urine, Biomarkers blood, Creatinine urine, Cystatin C urine, Female, Glomerular Filtration Rate, Humans, Kidney Failure, Chronic physiopathology, Kidney Failure, Chronic therapy, Male, Middle Aged, Peptide Fragments urine, Peritoneal Dialysis, Pilot Projects, Prospective Studies, Agrin blood, Blood Urea Nitrogen, Creatinine blood, Cystatin C blood, Kidney Failure, Chronic blood, Peptide Fragments blood
Abstract

Background: C-terminal agrin fragment (CAF, size 22 kDa) is a promising new biomarker for kidney function. This study evaluated the usefulness of CAF as a serum biomarker for residual renal function (RRF) in patients undergoing automated peritoneal dialysis (APD)., Patients and Methods: Serum, urine and dialysate samples were obtained in 12 end-stage renal disease patients undergoing APD. Total, renal and peritoneal clearances were calculated for CAF, creatinine, blood urea nitrogen (BUN) and cystatin c. kt/V was computed, and RRF (in ml/min) was calculated as the arithmetic mean of creatinine and BUN clearance. Correlations between the biomarkers' serum concentrations, clearances, kt/V and RRF were computed., Results: Serum CAF concentrations were highly correlated with serum concentrations of creatinine (r = 0.806, p = 0.002), BUN (r = 0.727, p = 0.007), cystatin c (r = 0.839, p = 0.001) and inversely to 24-h urinary output (r = -0.669, p = 0.017). RRF was inversely correlated with serum concentrations of CAF, cystatin c and creatinine being highest for CAF (r = -0.734, p = 0.007) followed by cystatin c (r = -0.65, p = 0.022) and creatinine (r = -0.606, p = 0.037). Serum BUN was not significantly associated with RRF (r = -0.497, p = 0.101). Age, weight and gender did not significantly affect serum CAF concentrations., Conclusion: Serum CAF provides a robust serum biomarker for RRF in peritoneal dialysis patients undergoing APD, possibly outperforming the value of conventional biomarkers.

Published
2015
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8. Influence of high-flux hemodialysis and hemodiafiltration on serum C-terminal agrin fragment levels in end-stage renal disease patients.

Author

Steubl D, Hettwer S, Dahinden P, Wolf P, Luppa P, Wagner CA, Küchle C, Schmaderer C, Renders L, Heemann U, and Roos M

Subjects
Adult, Aged, Agrin blood, Agrin genetics, Biomarkers, Dialysis Solutions chemistry, Female, Humans, Kidney metabolism, Kidney Failure, Chronic therapy, Male, Middle Aged, Agrin metabolism, Hemodiafiltration methods, Kidney Failure, Chronic blood, Renal Dialysis methods
Abstract

C-terminal agrin fragment (CAF, 22 kDa) has been shown to be a promising new rapid biomarker for kidney function. This study evaluated the influence of hemodialysis (HD) and hemodiafiltration (HDF) treatment on serum CAF concentrations in patients with end-stage renal disease (ESRD). A total of 36 patients with ESRD undergoing chronic HD/HDF treatment were enrolled (21 high-flux-HD/Fx60 membrane, 7 high-flux-HD/Elisio19H membrane, and 8 HDF/Elisio19H membrane). On a midweek session, blood samples were obtained before, at halftime, and post-treatment. Dialysate samples were obtained 4 times during treatment. Serum and dialysate CAF, cystatin C, urea, and creatinine concentrations were measured. Reduction ratios (RRs), total solute removal, overall dialytic clearance, and instantaneous dialytic clearance at halftime were calculated and compared. Although HD/Elisio19H and HDF/Elisio19H treatments significantly reduced CAF concentrations (RR 46.6 ± 9.1% and 57.6 ± 11.7%, respectively, P = 0.018 and P = 0.001), HD/Fx60 treatment did not remove CAF from serum (RR 2.4 ± 15.4%, P = 0.25), there was no relevant CAF detection in dialysate. In the HD/Fx60 group, the RR of CAF was significantly lower compared with cystatin C, urea, and creatinine, in which significant removal was detected (37.9 ± 14.8%, 65.0 ± 10.7%, and 56.0 ± 9.8%, respectively, P < 0.001). CAF is a new biomarker for kidney function whose serum concentration is not influenced by conventional high-flux HD using Fx60 membrane. It might therefore represent a promising dialysis-independent biomarker for evaluation of kidney function, for example, in acute kidney failure., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Published
2014
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9. [Chronic renal failure and transplantation].

Author

Kunzendorf U, Renders L, and Ziegler E

Subjects
Graft Rejection drug therapy, Graft Rejection etiology, Humans, Immunosuppressive Agents adverse effects, Immunosuppressive Agents therapeutic use, Kidney Function Tests, Living Donors, Opportunistic Infections etiology, Postoperative Complications etiology, Quality of Life, Renal Replacement Therapy, Tissue and Organ Procurement, Kidney Failure, Chronic surgery, Kidney Transplantation
Abstract

Kidney transplantation is the best option for all patients with terminal renal failure. Kidney transplantation is not only associated with an improved quality of life in comparison to all other renal replacement therapies, this method also offers a significantly extended lifespan. Therefore, the option for transplantation has to be verified for every patient with renal failure. Graft and patient survival is best when transplantation is carried out just before starting dialysis treatment. Realistically, only living donor transplantation offers the option of sparing the recipient a long waiting period on dialysis. Although transplantation from living donors is superior to cadaveric kidney transplantation, a small risk remains for the donor. Kidney transplantation and the immunosuppressive therapy are associated with an increased risk for certain types of infection, an increased tumour risk and an increased risk for cardiovascular complications. To address these problems, specific recommendations for patient surveillance have been provided by different transplantation societies.

Published
2007
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10. Lithium acetate therapy in a maintenance hemodialysis patient.

Author

Walcher J, Schoecklmann H, and Renders L

Subjects
Acetates blood, Acetates pharmacokinetics, Antidepressive Agents blood, Antidepressive Agents pharmacokinetics, Depressive Disorder, Major complications, Humans, Kidney Failure, Chronic therapy, Middle Aged, Acetates administration & dosage, Antidepressive Agents administration & dosage, Depressive Disorder, Major drug therapy, Kidney Failure, Chronic complications, Renal Dialysis
Abstract

Background/aims: Single cases of lithium carbonate dosing in hemodialysis patients have been published. We investigate the dose-serum level relationship after single and multiple lithium acetate dosing in a hemodialysis patient and review the literature., Methods: Lithium acetate was administered orally over a period of 11 months in a patient with major depressive episodes after being placed on hemodialysis three times a week. The serum trough levels of lithium before and after hemodialysis were analyzed. The data were compared with those reported in the literature, and potential drug interactions and the importance of the residual renal function are discussed., Results: No adverse events due to the lithium therapy were documented. Steady state levels of between 0.6 and 0.8 mmol/l of lithium acetate were achieved 17 days after initiating the therapy, using 24 mmol/l of lithium three times a week, in a patient with a residual diuresis of about 400 ml/day. In contrast, data reported in the literature implicate that only 9.6-14.4 mmol/l of lithium (450-600 mg of lithium carbonate) is sufficient to achieve adequate serum levels., Conclusions: The residual renal function can be important for lithium clearance. The creatinine clearance does not reflect this point., (Copyright 2004 S. Karger AG, Basel)

Published
2004
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11. Effect of Cinacalcet on Cardiovascular Disease in Patients Undergoing Dialysis

Author

Chertow GM, Block GA, Correa-Rotter R, Drüeke TB, Floege J, Goodman WG, Herzog CA, Kubo Y, London GM, Mahaffey KW, Mix TC, Moe SM, Trotman ML, Wheeler DC, Parfrey PS., Evolve Team, Chertow G, Parfrey P, Block G, Drüeke T, Goodman W, Herzog C, London G, Mahaffey K, Moe S, Wheeler D, Hennekens C, Baigent C, Brown W, O'Brien P, Anderson S, Hoel J, Szczech L, Patel U, Wampole J, Pun P, Felker M, Inrig J, Shah S, Hernandez A, Patel C, Brennan M, Albizem M, Capper E, Cauchi L, Cheng S, Dehmel B, Dhami K, Durham C, Francioni M, Gadd S, Goodman B, Guimaraes L, Grey N, Hamlin R, Harris C, Harris E, Heavey S, Heiges T, Heiser D, Jaeger P, James M, James P, Karimi S, Kewalramani R, Kraszewski A, Liang J, Maguire J, McCormick K, McFarlane K, Mix C, Modafferi D, Prathikanti R, Ryan C, Santiago N, Schumacher J, Seder C, Shahinfar S, Soares B, Stolman D, Tisher C, Trotman M, Tseng S, Ulias G, Unger P, Vyshenskaya A, Walsh L, White C, Wilde K, Santos J, Zarazaga C, Marin I, Garrote N, Cusumano A, Penalba N, Del Valle E, Juncos L, Saye J, Lef L, Altobelli V, Petraglia G, Rosa-Diez G, Douthat W, Lobo J, Gallart C, Lafalla A, Diez G, Linares B, Lopez N, Ramirez N, Gonzalez R, Valtuille R, Beresan H, Hermida O, Rudolf G, Marchetta N, Rano M, Ramirez M, Garcia N, Gillies A, Jones B, Pedagogos E, Walker R, Talaulikar G, Bannister K, Suranyi M, Kark A, Roger S, Kerr P, Disney A, Mount P, Fraenkel M, Mathew M, Fassett R, Jose M, Hawley C, Lonergan M, Mackie J, Ferrari P, Menahem S, Sabto J, Hutchison B, Langham R, Pollock C, Holzer H, Oberbauer R, Arias I, Graf H, Mayer G, Lhotta K, Neyer U, Klauser-Braun R, Hoerl W, Horn S, Kovarik J, Kramar R, Eigner M, Dhaene M, Billiouw J, De Meester J, Warling X, Cambier-Dwelschauwers P, Evenepoel P, Daelemans R, Dratwa M, Maes B, Stolear J, Dejagere T, Vanwalleghem J, Bouman K, Jadoul M, Peeters J, Vanholder R, Tielemans C, Donck J, Almeida F, de Oliveira J, Burdmann E, Garcia V, Thome F, Deboni L, Bregman R, Lugon J, Araújo S, Ferreira Filho S, Daher Ede F, Baptista M, Carvalho A, d'Avila D, Moyses Neto M, Yu L, Bastos M, Lacativa P, Jorgetti V, Romão Ede A, da Costa JC, Pecoits Filho R, Gordan P, Salgado N, Araújo M, Coelho S, Oliveira I, Moysés R, Vasconcellos L, Batista P, Gross J, Pedrosa A, Cournoyer S, LeBlanc M, Chow S, Karunakaran S, Wong G, Tobe S, Desmeules S, Zimmerman D, Murphy S, Montambault P, Donnelly S, MacRae J, Culleton B, Soroka S, Rabbat C, Jindal K, Vasilevsky M, Michaud M, Wijeyesinghe E, Zacharias J, Lok C, Muirhead N, Verrelli M, Da Roza G, Sapir D, Olgaard K, Daugaard H, Brandi L, Jensen P, Boulechfar H, Ang K, Simon P, Rieu P, Brunet P, Touchard G, Torres P, Combe C, Durrbach A, Ortiz J, Hannedouche T, Vela C, Lionet A, Ryckelynck P, Zaoui P, Choukroun G, Fessi H, Lang P, Stroumza P, Joly D, Mousson C, Laville M, Dellanna F, Erley C, Braun J, Rambausek M, Riegel W, Klingberg M, Schwertfeger E, Wizemann V, Eckardt K, Reichel H, Passauer J, Hübel E, Frischmuth N, Liebl R, Fiedler R, Schwenger V, Voßkühler A, Kunzendorf U, Renders L, Rattensberger D, Rump L, Ketteler M, Neumayer H, Zantvoort F, Stahl R, Ladanyi E, Braun B, Kulcsar I, Mezei I, Csiky B, Rikker C, Arkossy O, Berta K, Szegedi J, Major L, Ferenczi S, Fekete A, Szabo T, Zakar G, Wagner G, Erdelyine S, Borbas B, Eustace J, Reddan D, Capasso G, Locatelli F, Villa G, Cozzolino M, Brancaccio D, Messa P, Bolasco P, Ricciardi B, Malberti F, Moriero E, Cannella G, Ortalda V, Stefoni S, Frascà G, Cappelli G, Albertazzi A, Zoccali C, Farina M, Elli A, Avella F, Ondei P, Mingardi G, Errico R, Losito A, Di Giulio S, Pertosa G, Schena F, Grandaliano G, Gesualdo L, Auricchio M, Bochicchio-Ricardelli T, Correa-Rotter J, Verástegui F, Peña J, Wong A, Cruz-Valdez J, Zamora M, Solis M, Diaz M, Flores M, Sandoval E, van den Dorpel M, Brink H, Van Kuijk W, Vermeij C, Gregoor P, Hagen E, van der Sande F, Klinger M, Nowicki M, Muszytowski M, Bidas K, Bentkowski W, Wiecek A, Ksiazek A, Marczewski K, Ostrowski M, Switalski M, Sulowicz W, Matuszkiewicz-Rowinska J, Mysliwiec M, Durlik M, Rutkowski B, Macario F, Carvalho B, Frazao J, Machado D, Weigert A, Andrusev A, Khrustalev O, Zemtchenkov A, Gurevich K, Staroselsky K, Khadikova N, Rozhinskaya L, Timokhovskaya G, Strokov A, Balkarova O, Ermolenko V, Kolmakova E, Komandenko M, Timofeev M, Shilo V, Shostka G, Smirnov A, Anashkin V, Volgina G, Domashenko O, Gurevich A, Perlin D, García J, Ribes E, Piera E, Lucas M, Galicia M, Prados M, González M, Romero R, de Francisco ÁM, Montenegro J, Santiago C, García F, de La Ossa J, Arrieta J, Pons J, Martín-Malo A, Amigó J, Cases A, Sterner G, Jensen G, Wikström B, Jacobson S, Lund U, Weiss L, Ståhl A, von Albertini B, Burnier M, Meier P, Martin P, Uehlinger D, Dickenmann M, Yaqoob M, Zehnder D, Kalra P, Padmanabhan N, Roe S, Eadington D, Pritchard N, Hutchison A, Davies S, Wilkie M, Davies M, Pai P, Swift P, Kwan J, Goldsmith D, Tomson C, Stratton J, Dasgupta I, Sarkar S, Moustafa M, Gandhi K, Jamal A, Galindo-Ramos E, Tuazon J, Batlle D, Tucker K, Schiller-Moran B, Assefi A, Martinez C, Samuels L, Goldman J, Cangiano-Rivera J, Darwish R, Lee M, Topf J, Kapatkin K, Baer H, Kopelman R, Acharya M, Tharpe D, Bernardo M, Nader P, Guzman-Rivera J, Pergola P, Sekkarie M, Alas E, Zager P, Liss K, Navarro J, Roppolo M, Denu-Ciocca C, Kshirsagar A, El Khatib M, Kant K, Scott D, Murthyr B, Finkelstein F, Keightley G, McCrary R, Pitone J, Cavalieri T, Tsang A, Pellegrino B, Schmidt R, Ahmad S, Brown C, Friedman E, Mittman N, Fadem S, Shapiro W, Reddy M, Goldberger S, Woredekal Y, Agarwal A, Anger M, Haque M, Chidester P, Kohli R, Rubinstein S, Newman G, Gladish R, Ayodeji O, Soman S, Sprague S, Hunt N, Gehr T, Rizk D, Warnock D, Polack D, Pahl M, Fischer D, Dreyer P, James G, Husserl F, Rogers T, Raff A, Sedor J, Silver M, Smith M, Steinberg S, DelGiorno T, Jones E, Cunha P, Cheng J, Pogue V, Blumenthal S, Brown E, Charytan C, Buerkert J, Cook M, Felsenfeld A, Tareen N, Gupta A, Herman T, Diamond S, Hura C, Laski M, 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Cotton, J, Dhingra, R, Kleinman, L, Arif, F, Lew, S, Nammour, T, Sterrett, J, Williams, M, Ramirez, J, Rubin, J, Mccarthy, J, Noble, S, Chaffin, M, and Rekhi, A.

Subjects
Adult, Male, Dialysis, Cinacalcet, Cardiovascular Disease, medicine.medical_specialty, Calcimimetic, medicine.medical_treatment, Naphthalenes, Coronary artery disease, Renal Dialysis, Internal medicine, Odds Ratio, medicine, Humans, Intensive care medicine, Aged, Etelcalcetide, Hyperparathyroidism, Hypocalcemia, business.industry, General Medicine, Middle Aged, medicine.disease, Intention to Treat Analysis, Cardiovascular Diseases, Parathyroid Hormone, Cinacalcet Hydrochloride, Kidney Failure, Chronic, Female, Hyperparathyroidism, Secondary, Secondary hyperparathyroidism, business, medicine.drug
Abstract

Disorders of mineral metabolism, including secondary hyperparathyroidism, are thought to contribute to extraskeletal (including vascular) calcification among patients with chronic kidney disease. It has been hypothesized that treatment with the calcimimetic agent cinacalcet might reduce the risk of death or nonfatal cardiovascular events in such patients.In this clinical trial, we randomly assigned 3883 patients with moderate-to-severe secondary hyperparathyroidism (median level of intact parathyroid hormone, 693 pg per milliliter [10th to 90th percentile, 363 to 1694]) who were undergoing hemodialysis to receive either cinacalcet or placebo. All patients were eligible to receive conventional therapy, including phosphate binders, vitamin D sterols, or both. The patients were followed for up to 64 months. The primary composite end point was the time until death, myocardial infarction, hospitalization for unstable angina, heart failure, or a peripheral vascular event. The primary analysis was performed on the basis of the intention-to-treat principle.The median duration of study-drug exposure was 21.2 months in the cinacalcet group, versus 17.5 months in the placebo group. The primary composite end point was reached in 938 of 1948 patients (48.2%) in the cinacalcet group and 952 of 1935 patients (49.2%) in the placebo group (relative hazard in the cinacalcet group vs. the placebo group, 0.93; 95% confidence interval, 0.85 to 1.02; P=0.11). Hypocalcemia and gastrointestinal adverse events were significantly more frequent in patients receiving cinacalcet.In an unadjusted intention-to-treat analysis, cinacalcet did not significantly reduce the risk of death or major cardiovascular events in patients with moderate-to-severe secondary hyperparathyroidism who were undergoing dialysis. (Funded by Amgen; EVOLVE ClinicalTrials.gov number, NCT00345839.).

Published
2012

12. The effects of cinacalcet in older and younger patients on hemodialysis: The evaluation of cinacalcet HCL therapy to lower cardiovascular events (EVOLVE) trial

Author

P. Ryckelynck, Y. Woredekal, T. Gehr, Marian Klinger, J. Passauer, K. Liss, E. Del Valle, B. Linares, Ferdinando Avella, Stolear Jc, S. Tolkan, O. Hermida, V. Wizemann, Ricardo Correa-Rotter, J. Santos, Gert Mayer, Michael Anger, B. Pellegrino, B. Wikström, A. Ståhl, H. Al-Bander, Pedro Alejandro Gordan, Philip A. Kalra, E. Galindo-Ramos, Carmine Zoccali, G. Dolson, M. Eigner, Sanjay Dalal, G. Touchard, J Peeters, G. Da Roza, Shannon Murphy, R. Errico, M. Lonergan, A. Andrusev, H. Boulechfar, P. Zaoui, Michael Suranyi, de Francisco Martín de Francisco, S. Jacobson, B. Gupta, C. Stafford, J. Picollo de Oliveira, Ilka Regina Souza de Oliveira, F. Dumler, J. Martinez Saye, E. de Almeida Romão, Emmanuel A. Burdmann, C. Vermeij, N. Kumar, E. Shahmir, J. Stratton, R. Schmidt, Mario Cozzolino, Lars Christian Rump, Rainer Oberbauer, J. Kumar, M. Saklayen, Brian Hutchison, C. Denu-Ciocca, L. Weiss, E. Friedman, L. Renders, K. Gurevich, L. Brandi, W. Shapiro, Kym M. Bannister, K. Berta, Muhammad M. Yaqoob, C. Lok, A. Pedrosa, Rosa M.A. Moysés, K. Bhandari, J. Arrieta, T. Crouch, Brigitte Maes, G. Wong, Myriam González, Matthew R. P. Davies, R. Gonzalez, Geoffrey A. Block, T. Nammour, T. Youell, J. Ramirez, S. Tobe, N. Ramirez, T. Bochicchio-Ricardelli, J. Cangiano-Rivera, D. Streja, J. Endsley, K. Ang, R. Patak, J. Cheng, T. Rogers, Alberto Albertazzi, H. Holzer, G. Choukroun, Jose A.L. Arruda, Philippe Rieu, P. Simon, Stephen Z. Fadem, Jared G. Sugihara, H. Alfred, Bruce F. Culleton, G. Frascà, Giovanni Pertosa, W. Van Kuijk, H. Beresan, Samuel S. Blumenthal, Piergiorgio Messa, H. Baer, Michael C. Braun, B. Rutkowski, W. Riegel, M. Komandenko, V. Ermolenko, Martin Wilkie, N. Muirhead, Peter G. Kerr, D. Rattensberger, J. Sabto, Anjay Rastogi, L. Lef, M. El Shahawy, D. Tharpe, A. Smirnov, J. Pons, F. García, F. Zantvoort, A. Lionet, J. Topf, Marcia R. Silver, Reinhard Kramar, E. Moriero, A. Rekhi, S. Roe, P. Batista, E. Kolmakova, F. Rahim, M. Ostrowski, Janice P. Lea, Patrizia Ondei, C. Martinez, J. Donck, Nicole Lopez, F. Schena, Allen R. Nissenson, Alex P.S. Disney, R. Valtuille, C. Najun Zarazaga, M. Fraenkel, Pieter Evenepoel, R. Cottiero, S. Di Giulio, V. Gura, S. Karunakaran, P. Nader, F. Saldanha Thome, Walter Douthat, A. Fekete, L. Arbeit, W. Sulowicz, I. Marin, Charles R.V. Tomson, Andrzej Wiecek, Luis A. Juncos, G. Mingardi, P. Light, Max Dratwa, H. Reichel, R. Raja, U. Ranjit, G. Sterner, E. Coll Piera, P. Pai, Robert J. Walker, R. Bregman, E. Hübel, M. Timofeev, T. Szabo, A. Elli, N. Padmanabhan, N. Garrote, M. Mysliwiec, David C. Wheeler, J. Cruz-Valdez, R. Klauser, Maree-Ross Smith, Antonio Carlos Carvalho, A. Losito, M. Durlik, G. Petraglia, Gianni Cappelli, Y. Lien, M. Chaffin, N. García, R. Halligan, Glenn M. Chertow, M. Bastos, P. Smak Gregoor, S. Ong, M. Belledonne, Fredric O. Finkelstein, J. Martínez García, R. Pecoits Filho, M. Klingberg, B. Carvalho, S. Noble, T. Plumb, A. 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Subjects
Parathyroidectomy, Adult, Male, medicine.medical_specialty, Cinacalcet, Epidemiology, medicine.medical_treatment, Calcimimetic Agents, Critical Care and Intensive Care Medicine, Lower risk, Severity of Illness Index, CKD, cardiovascular disease, hemodialysis, hyperparathyroidism, mineral metabolism, Age Factors, Aged, Aged, 80 and over, Cardiovascular Diseases, Cinacalcet Hydrochloride, Female, Humans, Hyperparathyroidism, Secondary, Kidney Failure, Chronic, Kidney Transplantation, Middle Aged, Renal Dialysis, Nephrology, Transplantation, Internal medicine, medicine, Intensive care medicine, Hyperparathyroidism, business.industry, Original Articles, medicine.disease, Secondary hyperparathyroidism, Hemodialysis, business, medicine.drug
Abstract

Background andobjectivesThecalcimimeticcinacalcet reduced therisk of death or cardiovascular (CV) events in older, but not younger, patients with moderate to severe secondary hyperparathyroidism (HPT) who were receiving hemodialysis. To determine whether the lower risk in younger patients might be due to lower baseline CV risk and more frequent use of cointerventions that reduce parathyroid hormone (kidney transplantation, parathyroidectomy, and commercial cinacalcet use), this study examined the effects of cinacalcet in older ($65 years, n=1005) and younger (,65 years, n=2878) patients. Design, setting, participants, & measurements Evaluation of Cinacalcet HCl Therapy to Lower Cardiovascular Events (EVOLVE) was a global, multicenter, randomized placebo-controlled trial in 3883 prevalent patients on hemodialysis, whose outcomes included death, major CV events, and development of severe unremitting HPT. The age subgroup analysis was prespecified. ResultsOlderpatients hadhigher baselineprevalenceof diabetesmellitusandCV comorbidity. Annualizedrates of kidney transplantation and parathyroidectomy were .3-fold higher in younger relative to older patients and were more frequent in patients randomized to placebo. In older patients, the adjusted relative hazard (95% confidence interval) for the primary composite (CV) end point (cinacalcet versus placebo) was 0.70 (0.60 to 0.81); in younger patients, the relative hazard was 0.97 (0.86 to 1.09). Corresponding adjusted relative hazards for mortality were 0.68 (0.51 to 0.81) and 0.99 (0.86 to 1.13). Reduction in the risk of severe unremitting HPT was similar in both groups. Conclusions In the EVOLVE trial, cinacalcet decreased the risk of death and of major CV events in older, but not younger, patients with moderate to severe HPT who were receiving hemodialysis. Effect modification by age may be partly explained by differences in underlying CV risk and differential application of cointerventions that reduce parathyroid hormone. Clin J Am Soc Nephrol 10: ccc–ccc, 2015. doi: 10.2215/CJN.07730814

Published
2015

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