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2. A New Panel-Estimated GFR, Including β2-Microglobulin and β-Trace Protein and Not Including Race, Developed in a Diverse Population

Author

Inker, Lesley A, Couture, Sara J, Tighiouart, Hocine, Abraham, Alison G, Beck, Gerald J, Feldman, Harold I, Greene, Tom, Gudnason, Vilmundur, Karger, Amy B, Eckfeldt, John H, Kasiske, Bertram L, Mauer, Michael, Navis, Gerjan, Poggio, Emilio D, Rossing, Peter, Shlipak, Michael G, Levey, Andrew S, Collaborators, CKD-EPI GFR, Andresdottir, Margret B, Gudmundsdottir, Hrefna, Indridason, Olafur S, Palsson, Runolfur, Kimmel, Paul, Weir, Matt, Kalil, Roberto, Pesavento, Todd, Porter, Anna, Taliercio, Jonathan, Hsu, Chi-yuan, Chen, Jing, Sinkeler, Steef, Wyatt, Christina, Krishnasami, Zipporah, Hellinger, James, Margolick, Joseph, Kingsley, Lawrence, Witt, Mallory, Wolinsky, Steven, Shafi, Tariq, Post, Wendy, Doria, Alessandro, and Parving, Hans-Henrik

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, 4.2 Evaluation of markers and technologies, Detection, screening and diagnosis, Renal and urogenital, Adolescent, Adult, Black or African American, Aged, Aged, 80 and over, Black People, Case-Control Studies, Chromium Radioisotopes, Creatinine, Cystatin C, Edetic Acid, Female, Glomerular Filtration Rate, Humans, Intramolecular Oxidoreductases, Iohexol, Iothalamic Acid, Lipocalins, Male, Middle Aged, Renal Insufficiency, Chronic, Reproducibility of Results, Severity of Illness Index, White People, Young Adult, beta 2-Microglobulin, CKD-EPI GFR Collaborators, African American, Black race, GFR estimation, Glomerular filtration rate, bias, creatinine, cystatin C, estimating equations, filtration marker, kidney disease diagnosis, laboratory testing, race, race-based medicine, renal function, β(2)-microglobulin, β-trace protein, Public Health and Health Services, Urology & Nephrology, Clinical sciences
Abstract

Rationale and objectiveGlomerular filtration rate (GFR) estimation based on creatinine and cystatin C (eGFRcr-cys) is more accurate than estimated GFR (eGFR) based on creatinine or cystatin C alone (eGFRcr or eGFRcys, respectively), but the inclusion of creatinine in eGFRcr-cys requires specification of a person's race. β2-Microglobulin (B2M) and β-trace protein (BTP) are alternative filtration markers that appear to be less influenced by race than creatinine is.Study designStudy of diagnostic test accuracy.Setting and participantsDevelopment in a pooled population of 7 studies with 5,017 participants with and without chronic kidney disease. External validation in a pooled population of 7 other studies with 2,245 participants.Tests comparedPanel eGFR using B2M and BTP in addition to cystatin C (3-marker panel) or creatinine and cystatin C (4-marker panel) with and without age and sex or race.OutcomesGFR measured as the urinary clearance of iothalamate, plasma clearance of iohexol, or plasma clearance of [51Cr]EDTA.ResultsMean measured GFRs were 58.1 and 83.2 mL/min/1.73 m2, and the proportions of Black participants were 38.6% and 24.0%, in the development and validation populations, respectively. In development, addition of age and sex improved the performance of all equations compared with equations without age and sex, but addition of race did not further improve the performance. In validation, the 4-marker panels were more accurate than the 3-marker panels (P < 0.001). The 3-marker panel without race was more accurate than eGFRcys (percentage of estimates greater than 30% different from measured GFR [1 - P30] of 15.6% vs 17.4%; P = 0.01), and the 4-marker panel without race was as accurate as eGFRcr-cys (1 - P30 of 8.6% vs 9.4%; P = 0.2). Results were generally consistent across subgroups.LimitationsNo representation of participants with severe comorbid illness and from geographic areas outside of North America and Europe.ConclusionsThe 4-marker panel eGFR is as accurate as eGFRcr-cys without requiring specification of race. A more accurate race-free eGFR could be an important advance.

Published
2021

5. Change in albuminuria and subsequent risk of end-stage kidney disease: an individual participant-level consortium meta-analysis of observational studies

Author

Appel, Lawrence J, Greene, Tom, Chen, Teresa K, Chalmers, John, Arima, Hisatomi, Perkovic, Vlado, Levin, Adeera, Djurdjev, Ognjenka, Tang, Mila, Nally, Joseph, Navaneethan, Sankar D, Schold, Jesse D, Weldegiorgis, Misghina, Herrington, William G, Smith, Margaret, Hsu, C Yenchih, Hwang, Shih-Jen, Chang, Alex R, Kirchner, H. Lester, Green, Jamie A, Ho, Kevin, Marks, Angharad, Prescott, Gordon, Clark, Laura E, Fluck, Nick, Shalev, Varda, Chodick, Gabriel, Blankestijn, Peter J, Van Zuilen, Arjan, Van den Brand, Jan A, Sarnak, Mark J, Bottinger, Erwin, Nadkarni, Girish N, Ellis, Stephen G, Nadukuru, Rajiv, Metzger, Marie, Flamant, Martin, Houillier, Pascal, Haymann, Jean-Philippe, Froissart, Marc, Kenealy, Timothy, Elley, Raina C, Collins, John F, Drury, Paul L, Cuddeback, John K, Ciemins, Elizabeth L, Stempniewicz, Rich, Nelson, Robert G, Knowler, William C, Bakker, Stephen J, Major, Rupert W, Medcalf, James F, Shepherd, David, Barrett-Connor, Elizabeth, Bergstrom, Jaclyn, Ix, Joachim H, Molnar, Miklos Z, Sumida, Keiichi, de Zeeuw, Dick, Brenner, Barry, Qureshi, Abdul R, Elinder, Carl-Gustaf, Runesson, Bjorn, Evans, Marie, Segelmark, Marten, Stendahl, Maria, Schön, Staffan, Naimark, David M, Tangri, Navdeep, Sud, Maneesh, Hirayama, Atsushi, Ichikawa, Kazunobu, Bilo, Henk JG, Landman, Gijs WD, Van Hateren, Kornelis JJ, Kleefstra, Nanne, Hallan, Stein I, Ballew, Shoshana H, Chen, Jingsha, Kwak, Lucia, Surapaneni, Aditya, Parving, Hans-Henrik, Rodby, Roger A., Rohde, Richard D, Lewis, Julia B, Lewis, Edmund, Perrone, Ronald D, Abebe, Kaleab Z, Hou, Fan F, Xie, Di, Hunsicker, Lawrence G, Imai, Enyu, Kobayashi, Fumiaki, Makino, Hirofumi, Ito, Sadayoshi, Remuzzi, Giuseppe, Ruggenenti, Piero, Eckardt, Kai-Uwe, Gudmundsdottir, Hrefna, Maciulaitis, Romaldas, Manley, Tom, Smith, Kimberly, Stockbridge, Norman, Thompson, Aliza, Vetter, Thorsten, Willis, Kerry, Zhang, Luxia, Coresh, Josef, Heerspink, Hiddo J L, Sang, Yingying, Matsushita, Kunihiro, Arnlov, Johan, Astor, Brad C, Black, Corri, Brunskill, Nigel J, Carrero, Juan-Jesus, Feldman, Harold I, Fox, Caroline S, Inker, Lesley A, Ishani, Areef, Jassal, Simerjot, Konta, Tsuneo, Polkinghorne, Kevan, Romundstad, Solfrid, Solbu, Marit D, Stempniewicz, Nikita, Stengel, Benedicte, Tonelli, Marcello, Umesawa, Mitsumasa, Waikar, Sushrut S, Wen, Chi-Pang, Wetzels, Jack F M, Woodward, Mark, Grams, Morgan E, Kovesdy, Csaba P, Levey, Andrew S, and Gansevoort, Ron T

Published
2019
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6. Change in albuminuria as a surrogate endpoint for progression of kidney disease: a meta-analysis of treatment effects in randomised clinical trials

Author

Sevillano, Angel, Kamper, Anne-Lise, van Zuilen, Arjan D., Brenner, Barry M., Maes, Bart, Ihle, Benno U., Barret, Brendan, Leung, CB, Szeto, CC, Fitzner, Christina, Wanner, Christoph, Pozzi, Claudio, Montagnino, Claudio Ponticelli, Xie, Di, de Zeeuw, Dick, Lewis, Edmund, Verde, Eduardo, Gutierrez, Eduardo, Imai, Enyu, Hou, Fan Fan, Caravaca, Fernando, Fervenza, Fernando C., Locatelli, Francesco, Schena, Francesco Paolo, Kobayashi, Fumiaki, Moroni, Gabriella, Becker, Gavin J., Beck, Gerald J., Appel, Gerald B., Frisch, Gershon, van Essen, GG, Maschio, Giuseppe, Remuzzi, Giuseppe, Montogrino, Giuseppe, Parving, Hans-Henrik, Heerspink, Hiddo J.L., Makino, Hirofumi, Jehan, Imitiaz, Wetzels, Jack F.M., Donadio, James, Dwyer, Jamie, van den Brand, Jan, Kusek, John, Lachin, John M., Luño, Jose, Lewis, Julia B., Floege, Jürgen, Abebe, Kaleab Z., Chow, KM, Hunsicker, Lawrence G., del Vecchio, Lucia, Carlo, Manno, Praga, Manuel, Goicoechea, Marian, von Eynatten, Maximilian, Poulter, Neil, Chaturvedi, Nish, Passerini, Patrizia, de Jong, Paul E., Blankestijn, Peter J., Li, Philip, Ruggenenti, Piero, Zucchelli, Pietro, Kincaid-Smith, Priscilla S., Hilgers, Ralf-Dieter, Estacio, Raymond O., Rohde, Richard D., Katafuchi, Ritsuko, Toto, Robert D., Schrier, Robert W., Rodby, Roger A., Perrone, Ronald D., Ito, Sadayoshi, Klahr, Saulo, Andrulli, Simeone, Strandgaard, Svend, Chan, Tak Mao, Hannedouche, Thierry P., Rauen, Thomas, Greene, Tom, Verdalles, Ursula, Perkovic, Vlado, Keane, William, Heerspink, Hiddo J L, Tighiouart, Hocine, Gansevoort, Ron T, Coresh, Josef, Simon, Andrew L, Lewis, Julia B, Levey, Andrew S, and Inker, Lesley A

Published
2019
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8. Baseline characteristics in the Bardoxolone methyl EvAluation in patients with Chronic kidney disease and type 2 diabetes mellitus: the Occurrence of renal eveNts (BEACON) trial

Author

Heerspink, Hiddo J Lambers, Chertow, Glenn M, Akizawa, Tadao, Audhya, Paul, Bakris, George L, Goldsberry, Angie, Krauth, Melissa, Linde, Peter, McMurray, John J, Meyer, Colin J, Parving, Hans-Henrik, Remuzzi, Giuseppe, Christ-Schmidt, Heidi, Toto, Robert D, Vaziri, Nosratola D, Wanner, Christoph, Wittes, Janet, Wrolstad, Danielle, and de Zeeuw, Dick

Subjects
Clinical Research, Cardiovascular, Clinical Trials and Supportive Activities, Prevention, Hypertension, Kidney Disease, Diabetes, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Metabolic and endocrine, Renal and urogenital, Adolescent, Adult, Aged, Biomarkers, Cardiovascular Diseases, Diabetes Mellitus, Type 2, Diabetic Nephropathies, Double-Blind Method, Female, Glomerular Filtration Rate, Humans, Male, Middle Aged, Oleanolic Acid, Prognosis, Renal Insufficiency, Chronic, Young Adult, Bardoxolone, BEACON, diabetic nephropathy, RCT, Clinical Sciences, Urology & Nephrology
Abstract

BackgroundType 2 diabetes mellitus (T2DM) is the most important contributing cause of end-stage renal disease (ESRD) worldwide. Bardoxolone methyl, a nuclear factor-erythroid-2-related factor 2 activator, augments estimated glomerular filtration. The Bardoxolone methyl EvAluation in patients with Chronic kidney disease and type 2 diabetes mellitus: the Occurrence of renal eveNts (BEACON) trial was designed to establish whether bardoxolone methyl slows or prevents progression to ESRD. Herein, we describe baseline characteristics of the BEACON population.MethodsBEACON is a randomized double-blind placebo-controlled clinical trial in 2185 patients with T2DM and chronic kidney disease stage 4 (eGFR between 15 and 30 mL/min/1.73 m(2)) designed to test the hypothesis that bardoxolone methyl added to guideline-recommended treatment including inhibitors of the renin-angiotensin-aldosterone system slows or prevents progression to ESRD or cardiovascular death compared with placebo.ResultsBaseline characteristics (mean or percentage) of the population include age 68.5 years, female 43%, Caucasian 78%, eGFR 22.5 mL/min/1.73 m(2) and systolic/diastolic blood pressure 140/70 mmHg. The median urinary albumin:creatinine ratio was 320 mg/g and the frequency of micro- and macroalbuminuria was 30 and 51%, respectively. Anemia, abnormalities in markers of bone metabolism and elevations in cardiovascular biomarkers were frequently observed. A history of cardiovascular disease was present in 56%, neuropathy in 47% and retinopathy in 41% of patients.ConclusionsThe BEACON trial enrolled a population heretofore unstudied in an international randomized controlled trial. Enrolled patients suffered with numerous co-morbid conditions and exhibited multiple laboratory abnormalities, highlighting the critical need for new therapies to optimize management of these conditions.

Published
2013

9. Baseline characteristics in the Bardoxolone methyl EvAluation in patients with Chronic kidney disease and type 2 diabetes mellitus: the Occurrence of renal eveNts (BEACON) trial.

Author

Lambers Heerspink, Hiddo J, Chertow, Glenn M, Akizawa, Tadao, Audhya, Paul, Bakris, George L, Goldsberry, Angie, Krauth, Melissa, Linde, Peter, McMurray, John J, Meyer, Colin J, Parving, Hans-Henrik, Remuzzi, Giuseppe, Christ-Schmidt, Heidi, Toto, Robert D, Vaziri, Nosratola D, Wanner, Christoph, Wittes, Janet, Wrolstad, Danielle, and de Zeeuw, Dick

Subjects
Humans, Diabetic Nephropathies, Cardiovascular Diseases, Diabetes Mellitus, Type 2, Oleanolic Acid, Glomerular Filtration Rate, Prognosis, Double-Blind Method, Adolescent, Adult, Aged, Middle Aged, Female, Male, Renal Insufficiency, Chronic, Young Adult, Biomarkers, BEACON, Bardoxolone, RCT, diabetic nephropathy, Diabetes Mellitus, Type 2, Biological Markers, Renal Insufficiency, Chronic, Urology & Nephrology, Clinical Sciences
Abstract

BackgroundType 2 diabetes mellitus (T2DM) is the most important contributing cause of end-stage renal disease (ESRD) worldwide. Bardoxolone methyl, a nuclear factor-erythroid-2-related factor 2 activator, augments estimated glomerular filtration. The Bardoxolone methyl EvAluation in patients with Chronic kidney disease and type 2 diabetes mellitus: the Occurrence of renal eveNts (BEACON) trial was designed to establish whether bardoxolone methyl slows or prevents progression to ESRD. Herein, we describe baseline characteristics of the BEACON population.MethodsBEACON is a randomized double-blind placebo-controlled clinical trial in 2185 patients with T2DM and chronic kidney disease stage 4 (eGFR between 15 and 30 mL/min/1.73 m(2)) designed to test the hypothesis that bardoxolone methyl added to guideline-recommended treatment including inhibitors of the renin-angiotensin-aldosterone system slows or prevents progression to ESRD or cardiovascular death compared with placebo.ResultsBaseline characteristics (mean or percentage) of the population include age 68.5 years, female 43%, Caucasian 78%, eGFR 22.5 mL/min/1.73 m(2) and systolic/diastolic blood pressure 140/70 mmHg. The median urinary albumin:creatinine ratio was 320 mg/g and the frequency of micro- and macroalbuminuria was 30 and 51%, respectively. Anemia, abnormalities in markers of bone metabolism and elevations in cardiovascular biomarkers were frequently observed. A history of cardiovascular disease was present in 56%, neuropathy in 47% and retinopathy in 41% of patients.ConclusionsThe BEACON trial enrolled a population heretofore unstudied in an international randomized controlled trial. Enrolled patients suffered with numerous co-morbid conditions and exhibited multiple laboratory abnormalities, highlighting the critical need for new therapies to optimize management of these conditions.

Published
2013

18. The effect of insulin degludec on risk of symptomatic nocturnal hypoglycaemia in adults with type 1 diabetes and high risk of nocturnal severe hypoglycaemia (the HypoDeg trial): study rationale and design

Author

Agesen, Rikke Mette, Alibegovic, Amra Ciric, Andersen, Henrik Ullits, Beck-Nielsen, Henning, Gustenhoff, Peter, Hansen, Troels Krarup, Hedetoft, Christoffer, Jensen, Tonny, Juhl, Claus Bogh, Lerche, Susanne Søgaard, Nørgaard, Kirsten, Parving, Hans-Henrik, Tarnow, Lise, Thorsteinsson, Birger, and Pedersen-Bjergaard, Ulrik

Published
2019
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22. Longitudinal Assessment of the Effect of Atrasentan on Thoracic Bioimpedance in Diabetic Nephropathy: A Randomized, Double-Blind, Placebo-Controlled Trial

Author

Webb, David J., Coll, Blai, Heerspink, Hiddo J. L., Andress, Dennis, Pritchett, Yili, Brennan, John J., Houser, Mark, Correa-Rotter, Ricardo, Kohan, Donald, Makino, Hirofumi, Perkovic, Vlado, Remuzzi, Giuseppe, Tobe, Sheldon W., Toto, Robert, Busch, Robert, Pergola, Pablo, Parving, Hans-Henrik, and de Zeeuw, Dick

Published
2017
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24. Effect of insulin analogues on risk of severe hypoglycaemia in patients with type 1 diabetes prone to recurrent severe hypoglycaemia (HypoAna trial): a prospective, randomised, open-label, blinded-endpoint crossover trial

Author

Pedersen-Bjergaard, Ulrik, Kristensen, Peter Lommer, Beck-Nielsen, Henning, Nørgaard, Kirsten, Perrild, Hans, Christiansen, Jens Sandahl, Jensen, Tonny, Hougaard, Philip, Parving, Hans-Henrik, Thorsteinsson, Birger, and Tarnow, Lise

Published
2014
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25. Estimated GFR Decline as a Surrogate End Point for Kidney Failure: A Post Hoc Analysis From the Reduction of End Points in Non–Insulin-Dependent Diabetes With the Angiotensin II Antagonist Losartan (RENAAL) Study and Irbesartan Diabetic Nephropathy Trial (IDNT)

Author

Lambers Heerspink, Hiddo J., Weldegiorgis, Misghina, Inker, Lesley A., Gansevoort, Ron, Parving, Hans-Henrik, Dwyer, Jamie P., Mondal, Hasi, Coresh, Josef, Greene, Tom, Levey, Andrew S., and de Zeeuw, Dick

Published
2014
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26. Effect of insulin degludec versus insulin glargine U100 on nocturnal glycaemia assessed by plasma glucose profiles in people with type 1 diabetes prone to nocturnal severe hypoglycaemia.

Author

Brøsen, Julie Maria Bøggild, Agesen, Rikke Mette, Kristensen, Peter Lommer, Alibegovic, Amra Ciric, Andersen, Henrik Ullits, Beck‐Nielsen, Henning, Gustenhoff, Peter, Hansen, Troels Krarup, Hedetoft, Christoffer, Jensen, Tonny, Stolberg, Charlotte Røn, Juhl, Claus Bogh, Lerche, Susanne Søgaard, Nørgaard, Kirsten, Parving, Hans‐Henrik, Tarnow, Lise, Thorsteinsson, Birger, and Pedersen‐Bjergaard, Ulrik

Subjects
BLOOD sugar, INSULIN aspart, TYPE 1 diabetes, DESMOPRESSIN, HYPOGLYCEMIA, INSULIN, INSULIN therapy, GLUCOSE
Abstract

Aim: To compare nocturnal glucose profiles according to hourly plasma glucose measurements during treatment with insulin degludec and insulin glargine U100 in a cohort of people with type 1 diabetes prone to nocturnal severe hypoglycaemia. Materials and methods: The HypoDeg trial is a 2‐year investigator‐initiated, randomized, controlled crossover trial in 149 participants randomized to treatment with insulin degludec and insulin glargine U100 for 12 months each. The 51 participants in this predefined substudy stayed at least one night in hospital during each treatment arm for plasma glucose samples to be taken. Endpoints were glucose profiles, including mean plasma glucose, glycaemic variability and risk of hypoglycaemia. Results: There were no differences between treatments regarding mean plasma glucose. We saw a flatter glucose profile during insulin degludec compared with insulin glargine U100 treatment, which had a nadir at 4:00 AM, with a subsequent rise. During treatment with insulin degludec, the participants had lower glycaemic variability, with an estimated treatment difference of −4.3% (95% confidence interval [CI] −8.1 to −0.5; P < 0.05). Participants treated with insulin degludec were less likely to experience nocturnal hypoglycaemia below 3.0 mmol/L (hazard ratio 0.36 [95% CI 0.17‐0.73; P < 0.05]). Conclusion: Based on nocturnal plasma glucose measurements, treatment with insulin degludec compared with insulin glargine U100 administered in the evening results in lower glycaemic variability and lower risk of nocturnal hypoglycaemia without differences in mean plasma glucose. [ABSTRACT FROM AUTHOR]

Published
2023
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33. Marker for kidney fibrosis is associated with inflammation and deterioration of kidney function in people with type 2 diabetes and microalbuminuria.

Author

Poulsen, Christina Gjerlev, Rasmussen, Daniel G. K., Genovese, Federica, Hansen, Tine W., Nielsen, Signe Holm, Reinhard, Henrik, von Scholten, Bernt Johan, Jacobsen, Peter K., Parving, Hans-Henrik, Karsdal, Morten Asser, Rossing, Peter, and Frimodt-Møller, Marie

Subjects
RENAL fibrosis, DISEASE risk factors, TYPE 2 diabetes, DIABETIC nephropathies, KIDNEY physiology, RENIN-angiotensin system
Abstract

Background: Diabetic kidney disease is a major cause of morbidity and mortality. Dysregulated turnover of collagen type III is associated with development of kidney fibrosis. We investigated whether a degradation product of collagen type III (C3M) was a risk marker for progression of chronic kidney disease (CKD), occurrence of cardiovascular disease (CVD), and mortality during follow up in people with type 2 diabetes (T2D) and microalbuminuria. Moreover, we investigated whether C3M was correlated with markers of inflammation and endothelial dysfunction at baseline. Methods: C3M was measured in serum (sC3M) and urine (uC3M) in 200 participants with T2D and microalbuminuria included in an observational, prospective study at Steno Diabetes Center Copenhagen in Denmark from 2007–2008. Baseline measurements included 12 markers of inflammation and endothelial dysfunction. The endpoints were CVD, mortality, and CKD progression (>30% decline in eGFR). Results: Mean (SD) age was 59 (9) years, eGFR 90 (17) ml/min/1.73m2 and median (IQR) urine albumin excretion rate 102 (39–229) mg/24-h. At baseline all markers for inflammation were positively correlated with sC3M (p≤0.034). Some, but not all, markers for endothelial dysfunction were correlated with C3M. Median follow-up ranged from 4.9 to 6.3 years. Higher sC3M was associated with CKD progression (with mortality as competing risk) with a hazard ratio (per doubling) of 2.98 (95% CI: 1.41–6.26; p = 0.004) adjusted for traditional risk factors. uC3M was not associated with CKD progression. Neither sC3M or uC3M were associated with risk of CVD or mortality. Conclusions: Higher sC3M was a risk factor for chronic kidney disease progression and was correlated with markers of inflammation. [ABSTRACT FROM AUTHOR]

Published
2023
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34. SORBS1 gene, a new candidate for diabetic nephropathy: results from a multi-stage genome-wide association study in patients with type 1 diabetes

Author

Germain, Marine, Pezzolesi, Marcus G., Sandholm, Niina, McKnight, Amy J., Susztak, Katalin, Lajer, Maria, Forsblom, Carol, Marre, Michel, Parving, Hans-Henrik, Rossing, Peter, Toppila, Iiro, Skupien, Jan, Roussel, Ronan, Ko, Yi-An, Ledo, Nora, Folkersen, Lasse, Civelek, Mete, Maxwell, Alexander P., Tregouet, David-Alexandre, Groop, Per-Henrik, Tarnow, Lise, and Hadjadj, Samy

Published
2015
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37. Prediction of the effect of atrasentan on renal and heart failure outcomes based on short-term changes in multiple risk markers

Author

Schievink, Bauke, de Zeeuw, Dick, Smink, Paul A, Andress, Dennis, Brennan, John J, Coll, Blai, Correa-Rotter, Ricardo, Hou, Fan Fan, Kohan, Donald, Kitzman, Dalane W, Makino, Hirofumi, Parving, Hans-Henrik, Perkovic, Vlado, Remuzzi, Giuseppe, Tobe, Sheldon, Toto, Robert, Hoekman, Jarno, and Heerspink, Hiddo Lambers J

Published
2016
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49. Organic Anion Transporter Gene Variants Associated With Plasma Exposure and Long‐Term Response to Atrasentan in Patients With Diabetic Kidney Disease.

Author

Smeijer, J. David, Koomen, Jeroen V., Kohan, Donald E., McMurray, John J. V., Bakris, George L., Correa‐Rotter, Ricardo, Hou, Fan‐Fan, Kitzman, Dalane W., Makino, Hirofumi, Mayer, Gert, Nowicki, Michal, Perkovic, Vlado, Rossing, Peter, Tobe, Sheldon, Parving, Hans‐Henrik, de Zeeuw, Dick, and Heerspink, Hiddo J. L.

Subjects
DIABETIC nephropathies, ORGANIC anion transporters, ENDOTHELIN receptors, GENETIC variation, SINGLE nucleotide polymorphisms, PEOPLE with diabetes, PROPORTIONAL hazards models, MEMBRANE transport proteins
Abstract

Plasma exposure of the endothelin receptor antagonist atrasentan varies between individuals and is associated with nephroprotective effects and the risk of heart failure. We examined the influence of genetic polymorphisms on atrasentan plasma exposure and pharmacodynamic effects. We performed a substudy of the Study of Diabetic Nephropathy With Atrasentan (SONAR) trial which enrolled adults with type 2 diabetes and chronic kidney disease (estimated glomerular filtration rate: 25–75 mL/min/1.73 m2, and a urine albumin‐to‐creatinine ratio of 300–5,000 mg/g). Single nucleotide polymorphisms (SNPs) were determined for prespecified membrane transporters, metabolizing enzymes, and the endothelin‐1 peptide. The associations among genotype, atrasentan plasma exposure, and the effect of atrasentan on the prespecified kidney and heart failure hospitalization (HHF) outcomes was assessed with Cox proportional hazards regression models. Of 3,668 patients randomized, 2,329 (63.5%) consented to genotype analysis. Two SNPs in the SLCO1B1 gene (rs4149056 and rs2306283), encoding the hepatic organic anion transporter 1B1 (OATP1B1), showed the strongest association with atrasentan plasma exposure. Based on their SLCO1B1 genotype, patients were classified into normal (atrasentan area under the plasma‐concentration time curve from zero to infinity (AUC0−inf) 41.3 ng·h/mL) or slow (atrasentan AUC0−inf 49.7 ng·h/mL, P < 0.001) OATP1B1 transporter phenotypes. Among patients with a normal OATP1B1 phenotype, the hazard ratio (HR) with atrasentan for the primary kidney and HHF outcomes were 0.61 (95% confidence interval (CI): 0.45–0.81) and 1.35 (95% CI: 0.84–2.13), respectively. In the slow transporter phenotype, HRs for kidney and HHF outcomes were 1.95 (95% CI: 0.95–4.03, P‐interaction normal phenotype = 0.004), and 4.18 (95% CI: 1.37–12.7, P‐interaction normal phenotype = 0.060), respectively. OATP1B1 gene polymorphisms are associated with significant between‐patient variability in atrasentan plasma exposure and long‐term efficacy and safety. [ABSTRACT FROM AUTHOR]

Published
2022
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50. Continuous Glucose Monitoring-Recorded Hypoglycemia with Insulin Degludec or Insulin Glargine U100 in People with Type 1 Diabetes Prone to Nocturnal Severe Hypoglycemia.

Author

Brøsen, Julie Maria Bøggild, Agesen, Rikke Mette, Alibegovic, Amra Ciric, Ullits Andersen, Henrik, Beck-Nielsen, Henning, Gustenhoff, Peter, Krarup Hansen, Troels, Hedetoft, Christoffer Georg Riber, Jensen, Tonny Joran, Stolberg, Charlotte Røn, Bogh Juhl, Claus, Lerche, Susanne Søgaard, Nørgaard, Kirsten, Parving, Hans-Henrik, Tarnow, Lise, Thorsteinsson, Birger, and Pedersen-Bjergaard, Ulrik

Published
2022
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