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Start Over Author "Rush A" Journal american journal of transplantation
194 results on '"Rush A"'

8. First-in-human clinical trial to assess pharmacokinetics, pharmacodynamics, safety, and tolerability of iscalimab, an anti-CD40 monoclonal antibody

Author

Espié, Pascal, He, YanLing, Koo, Phillip, Sickert, Denise, Dupuy, Cyrielle, Chokoté, Edwige, Schuler, Roland, Mergentaler, Heidi, Ristov, Jacinda, Milojevic, Julie, Verles, Aurelie, Groenewegen, Andrea, Auger, Anita, Avrameas, Alexandre, Rotte, Michael, Colin, Laurence, Tomek, Charles S., Hernandez-Illas, Martha, Rush, James S., and Gergely, Peter

Published
2020
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9. Comparison of the effects of standard vs low-dose prolonged-release tacrolimus with or without ACEi/ARB on the histology and function of renal allografts

Author

Cockfield, Sandra M., Wilson, Sam, Campbell, Patricia M., Cantarovich, Marcelo, Gangji, Azim, Houde, Isabelle, Jevnikar, Anthony M., Keough-Ryan, Tammy M., Monroy-Cuadros, Felix-Mauricio, Nickerson, Peter W., Pâquet, Michel R., Ramesh Prasad, G.V., Senécal, Lynne, Shoker, Ahmed, Wolff, Jean-Luc, Howell, John, Schwartz, Jason J., and Rush, David N.

Published
2019
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12. Characterization of the in vitro and in vivo properties of CFZ533, a blocking and non-depleting anti-CD40 monoclonal antibody

Author

Ristov, Jacinda, Espie, Pascal, Ulrich, Peter, Sickert, Denise, Flandre, Thierry, Dimitrova, Mirela, Müller-Ristig, Dorothee, Weider, Doris, Robert, Gautier, Schmutz, Patrick, Greutmann, Barbara, Cordoba-Castro, Francisco, Schneider, Martin A., Warncke, Max, Kolbinger, Frank, Cote, Serge, Heusser, Christoph, Bruns, Christian, and Rush, James S.

Published
2018
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19. Banff 2013 Meeting Report: Inclusion of C4d-Negative Antibody-Mediated Rejection and Antibody-Associated Arterial Lesions

Author

Haas, M., Sis, B., Racusen, L.C., Solez, K., Glotz, D., Colvin, R.B., Castro, M.C.R., David, D.S.R., David-Neto, E., Bagnasco, S.M., Cendales, L.C., Cornell, L.D., Demetris, A.J., Drachenberg, C.B., Farver, C.F., Farris, A.B., III, Gibson, I.W., Kraus, E., Liapis, H., Loupy, A., Nickeleit, V., Randhawa, P., Rodriguez, E.R., Rush, D., Smith, R.N., Tan, C.D., Wallace, W.D., and Mengel, M.

Published
2014
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24. A noninferiority design for a delayed calcineurin inhibitor substitution trial in kidney transplantation

Author

Robert Balshaw, Nancy D. Bridges, Ian W. Gibson, Julie Ho, Chris Wiebe, Peter Nickerson, David N. Rush, and Peter S. Heeger

Subjects
Oncology, Graft Rejection, medicine.medical_specialty, Standard of care, Calcineurin Inhibitors, Renal function, Food and drug administration, immunosuppression / immune modulation, Internal medicine, clinical research / practice, medicine, Immunology and Allergy, Humans, Pharmacology (medical), Clinical efficacy, kidney transplantation / nephrology, Kidney transplantation, Transplantation, business.industry, Clinical study design, Graft Survival, Clinical Science, medicine.disease, Kidney Transplantation, clinical trial design, Calcineurin, rejection: acute, Sample size determination, Original Article, immunosuppressant ‐ calcineurin inhibitor (CNI), ORIGINAL ARTICLES, business, Immunosuppressive Agents
Abstract

Improving long‐term kidney transplant outcomes requires novel treatment strategies, including delayed calcineurin inhibitor (CNI) substitution, tested using informative trial designs. An alternative approach to the usual superiority‐based trial is a noninferiority trial design that tests whether an investigational agent is not unacceptably worse than standard of care. An informative noninferiority design, with biopsy‐proven acute rejection (BPAR) as the endpoint, requires determination of a prespecified, evidence‐based noninferiority margin for BPAR. No such information is available for delayed CNI substitution in kidney transplantation. Herein we analyzed data from recent kidney transplant trials of CNI withdrawal and “real world” CNI‐ based standard of care, containing subjects with well‐documented evidence of immune quiescence at 6 months posttransplant—ideal candidates for delayed CNI substitution. Our analysis indicates an evidence‐based noninferiority margin of 13.8% for the United States Food and Drug Administration's composite definition of BPAR between 6 and 24 months posttransplant. Sample size estimation determined that ~225 randomized subjects would be required to evaluate noninferiority for this primary clinical efficacy endpoint, and superiority for a renal function safety endpoint. Our findings provide the basis for future delayed CNI substitution noninferiority trials, thereby increasing the likelihood they will provide clinically implementable results and achieve regulatory approval., This meta‐analysis defines a noninferiority margin to use in the design of a phase II/III delayed calcineurin inhibitor substitution trial in kidney transplantation.

Published
2020

25. Evidence for the alloimmune basis and prognostic significance of Borderline T cell–mediated rejection

Author

Ian W. Gibson, Peter Nickerson, Julie Ho, Denise Pochinco, David N. Rush, Aviva Goldberg, Jamie Shaw, Chris Wiebe, Tom Blydt-Hansen, Martin Karpinski, and Patricia E. Birk

Subjects
Oncology, Graft Rejection, medicine.medical_specialty, major histocompatibility complex (MHC), medicine.medical_treatment, T cell, Patient risk, T-Lymphocytes, graft survival, risk assessment / risk stratification, 030230 surgery, T cell–mediated rejection (TCMR), 03 medical and health sciences, 0302 clinical medicine, immunosuppression / immune modulation, Internal medicine, Allograft survival, clinical research / practice, medicine, Immunology and Allergy, Humans, Pharmacology (medical), histocompatibility, kidney transplantation / nephrology, Transplantation, business.industry, Hazard ratio, Immunosuppression, Clinical Science, Prognosis, Kidney Transplantation, Tacrolimus, 3. Good health, Histocompatibility, medicine.anatomical_structure, Renal transplant, Original Article, ORIGINAL ARTICLES, business
Abstract

Prognostic biomarkers of T cell–mediated rejection (TCMR) have not been adequately studied in the modern era. We evaluated 803 renal transplant recipients and correlated HLA‐DR/DQ molecular mismatch alloimmune risk categories (low, intermediate, high) with the severity, frequency, and persistence of TCMR. Allograft survival was reduced in recipients with Banff Borderline (hazard ratio [HR] 2.4, P = .003) and Banff ≥ IA TCMR (HR 4.3, P, Alloimmune risk categorization using HLA‐DR/DQ molecular mismatch risk correlates with the severity, frequency, and persistence of T cell–mediated rejection and with graft survival, independent of de novo DSA.

Published
2020

29. Comparison of the effects of standard vs low-dose prolonged-release tacrolimus with or without ACEi/ARB on the histology and function of renal allografts

Author

Tammy Keough-Ryan, Patricia Campbell, Michel Pâquet, Isabelle Houde, Peter Nickerson, Jean‐Luc Wolff, Ahmed Shoker, Lynne Senécal, Jason J. Schwartz, Felix‐Mauricio Monroy‐Cuadros, Sam Wilson, Marcelo Cantarovich, G. V. Ramesh Prasad, John Howell, A. M. Jevnikar, Azim S. Gangji, Sandra M. Cockfield, and David N. Rush

Subjects
Graft Rejection, Male, Angiotensin receptor, graft survival, Angiotensin-Converting Enzyme Inhibitors, kidney transplantation/nephrology, immunosuppression/immune modulation, Kidney, law.invention, Renin-Angiotensin System, Randomized controlled trial, law, Immunology and Allergy, Medicine, organ transplantation in general, Pharmacology (medical), Prospective Studies, clinical trial, Middle Aged, Clinical Science, Allografts, Prognosis, Drug Therapy, Combination, Female, Original Article, Immunosuppressive Agents, Adult, medicine.medical_specialty, Urology, Renal function, clinical research/practice, Tacrolimus, immunosuppressant ‐ calcineurin inhibitor: tacrolimus, patient survival, Humans, Dosing, Polyomavirus Infections, Transplantation, business.industry, Histology, Fibrosis, Kidney Transplantation, Blockade, Clinical trial, Delayed-Action Preparations, Virus Activation, Atrophy, ORIGINAL ARTICLES, business, Angiotensin II Type 1 Receptor Blockers
Abstract

Targeting the renin‐angiotensin system and optimizing tacrolimus exposure are both postulated to improve outcomes in renal transplant recipients (RTRs) by preventing interstitial fibrosis/tubular atrophy (IF/TA). In this multicenter, prospective, open‐label controlled trial, adult de novo RTRs were randomized in a 2 × 2 design to low‐ vs standard‐dose (LOW vs STD) prolonged‐release tacrolimus and to angiotensin‐converting enzyme inhibitors/angiotensin II receptor 1 blockers (ACEi/ARBs) vs other antihypertensive therapy (OAHT). There were 2 coprimary endpoints: the prevalence of IF/TA at month 6 and at month 24. IF/TA prevalence was similar for LOW vs STD tacrolimus at month 6 (36.8% vs 39.5%; P = .80) and ACEi/ARBs vs OAHT at month 24 (54.8% vs 58.2%; P = .33). IF/TA progression decreased significantly with LOW vs STD tacrolimus at month 24 (mean [SD] change, +0.42 [1.477] vs +1.10 [1.577]; P = .0039). Across the 4 treatment groups, LOW + ACEi/ARB patients exhibited the lowest mean IF/TA change and, compared with LOW + OAHT patients, experienced significantly delayed time to first T cell–mediated rejection. Renal function was stable from month 1 to month 24 in all treatment groups. No unexpected safety findings were detected. Coupled with LOW tacrolimus dosing, ACEi/ARBs appear to reduce IF/TA progression and delay rejection relative to reduced tacrolimus exposure without renin‐angiotensin system blockade. ClinicalTrials.gov identifier: NCT00933231., The prevalence and progression of interstitial fibrosis and tubular atrophy over 24 months is reduced in adult de novo kidney transplant recipients who receive low‐dose prolonged release tacrolimus combined with renin‐angiotensin system (RAS) blockers compared to patients who receive low‐dose tacrolimus without RAS blockade or patients who receive standard dose tacrolimus with or without RAS blockade.

Published
2019
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42. Late graft failure after kidney transplantation as the consequence of late versus early events

Author

Robert E Leduc, Fernando G. Cosio, Arthur J. Matas, Bertram L. Kasiske, Sita Gourishankar, Ann M. Fieberg, J. Michael Cecka, John E. Connett, Joseph P. Grande, Roslyn B. Mannon, Lawrence G. Hunsicker, David N. Rush, and Robert S. Gaston

Subjects
Adult, Graft Rejection, Male, medicine.medical_specialty, Time Factors, Graft failure, 030232 urology & nephrology, Urology, Delayed Graft Function, 030230 surgery, 03 medical and health sciences, chemistry.chemical_compound, Postoperative Complications, 0302 clinical medicine, Risk Factors, Chronic allograft nephropathy, Biopsy, medicine, Humans, Immunology and Allergy, Pharmacology (medical), Prospective Studies, Kidney transplantation, Transplantation, Creatinine, Kidney, Proteinuria, medicine.diagnostic_test, business.industry, Graft Survival, Middle Aged, Prognosis, medicine.disease, Kidney Transplantation, Surgery, medicine.anatomical_structure, chemistry, Kidney Failure, Chronic, Female, medicine.symptom, business, Follow-Up Studies, Cohort study
Abstract

Beyond the first posttransplant year, 3% of kidney transplants fail annually. In a prospective, multicenter cohort study, we tested the relative impact of early versus late events on risk of long-term death-censored graft failure (DCGF). In grafts surviving at least 90 days, early events (acute rejection [AR] and delayed graft function [DGF] before day 90) were recorded; serum creatinine (Cr) at day 90 was defined as baseline. Thereafter, a 25% rise in serum Cr or new-onset proteinuria triggered graft biopsy (index biopsy, IBx), allowing comparison of risk of DCGF associated with early events (AR, DGF, baseline serum Cr >2.0 mg/dL) to that associated with later events (IBx). Among 3678 patients followed for 4.7 ± 1.9 years, 753 (20%) had IBx at a median of 15.3 months posttransplant. Early AR (HR = 1.77, P

Published
2018
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46. Evaluation of C1q Status and Titer of De Novo Donor-Specific Antibodies as Predictors of Allograft Survival

Author

Tom Blydt-Hansen, Peter Nickerson, Leroy Storsley, Martin Karpinski, Ian W. Gibson, Denise Pochinco, Aviva Goldberg, Julie Ho, Patricia E. Birk, David N. Rush, Alison J. Gareau, and Chris Wiebe

Subjects
Adult, Graft Rejection, Male, medicine.medical_specialty, 030232 urology & nephrology, Renal function, 030230 surgery, Kidney Function Tests, Gastroenterology, Isoantibodies, 03 medical and health sciences, 0302 clinical medicine, Risk Factors, Internal medicine, medicine, Humans, Immunology and Allergy, Pharmacology (medical), Survival rate, Kidney transplantation, Transplantation, biology, business.industry, Complement C1q, Graft Survival, Allografts, Prognosis, medicine.disease, Kidney Transplantation, Tissue Donors, Transplant Recipients, 3. Good health, Survival Rate, Titer, Cohort, Immunology, biology.protein, Kidney Failure, Chronic, Female, Antibody, business, Follow-Up Studies, Glomerular Filtration Rate
Abstract

De novo donor-specific antibodies (dnDSAs) that develop after renal transplantation are independent predictors of allograft loss. However, it is unknown if dnDSA C1q status or titer at the time of first detection can independently predict allograft loss. In a consecutive cohort of 508 renal transplant recipients, 70 developed dnDSAs. Histologic and clinical outcomes were correlated with the C1q assay or dnDSA titer. C1q positivity correlated with dnDSA titer (p < 0.01) and mean fluorescence intensity (p < 0.01) and was more common in class II versus class I dnDSAs (p < 0.01). C1q status correlated with tubulitis (p = 0.02) and C4d status (p = 0.03) in biopsies at the time of dnDSA development, but not T cell-mediated rejection (TCMR) or antibody-mediated rejection (ABMR). De novo DSA titer correlated with Banff g, i, t, ptc, C4d scores, TCMR (p < 0.01) and ABMR (p < 0.01). Post-dnDSA graft loss was observed more frequently in recipients with C1q-positve dnDSA (p < 0.01) or dnDSA titer ≥ 1:1024 (p ≤ 0.01). However, after adjustment for clinical phenotype and nonadherence in multivariate models, neither C1q status nor dnDSA titer were independently associated with allograft loss, questioning the utility of these assays at the time of dnDSA development.

Published
2017
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