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Wiley
2024
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| Online-Zugang: | https://onlinelibrary.wiley.com/doi/10.1111/ctr.70067 |
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| author | Patricia M. Campbell Marcelo Cantarovich Azim Gangji Isabelle Houde Anthony M. Jevnikar Felix‐Mauricio Monroy‐Cuadros Peter W. Nickerson Michel R. Pâquet G. V. Ramesh Prasad Lynne Senécal Jean‐Luc Wolff Jason J. Schwartz David N. Rush |
| author_facet | Patricia M. Campbell Marcelo Cantarovich Azim Gangji Isabelle Houde Anthony M. Jevnikar Felix‐Mauricio Monroy‐Cuadros Peter W. Nickerson Michel R. Pâquet G. V. Ramesh Prasad Lynne Senécal Jean‐Luc Wolff Jason J. Schwartz David N. Rush Patricia M. Campbell Marcelo Cantarovich Azim Gangji Isabelle Houde Anthony M. Jevnikar Felix‐Mauricio Monroy‐Cuadros Peter W. Nickerson Michel R. Pâquet G. V. Ramesh Prasad Lynne Senécal Jean‐Luc Wolff Jason J. Schwartz David N. Rush |
| collection | Wiley Open Access |
| contents | A Five‐Year Prospective, Randomized, Open‐Label Study of Standard‐Dose Versus Low‐Dose Prolonged‐Release Tacrolimus With or Without Angiotensin‐Converting Enzyme Inhibitor or Angiotensin II Receptor Blocker Post Kidney Transplantation Patricia M. Campbell Marcelo Cantarovich Azim Gangji Isabelle Houde Anthony M. Jevnikar Felix‐Mauricio Monroy‐Cuadros Peter W. Nickerson Michel R. Pâquet G. V. Ramesh Prasad Lynne Senécal Jean‐Luc Wolff Jason J. Schwartz David N. Rush Clinical Transplantation ABSTRACTIntroductionNovel approaches to improve long‐term outcomes in kidney transplant recipients are required. Here, we present the 5‐year data from a multicenter, prospective, Phase 3b trial evaluating treatment outcomes with standard (STD) or low (LOW) dose prolonged‐release tacrolimus (TAC) combined with ACEi/ARB or other antihypertensive therapy (OAHT) in Canadian kidney transplant recipients.MethodsAdult de novo kidney transplant recipients were randomized 2 × 2 to STD or LOW dose TAC and ACEi/ARB or OAHT. Patients had received a first or second transplant from a living or deceased donor and had ≥ 1 human leukocyte antigen mismatch with their donor.ResultsThere were 281 patients from 13 sites across Canada. Overall patient survival was 95.7% and was comparable between groups. Graft survival at study end was 89.7% in the LOW+OAHT group and 94.4%–97.1% in the other groups and BPAR, and Class II de novo donor‐specific antibodies (dnDSA) were higher in the LOW+OAHT group than in the other groups. However, these differences were not statistically significant. Graft function, blood pressure (BP), and proteinuria were similar between the groups; however, between 2 and 5 years there was a 2‐fold or greater increase in the use of ACEi/ARB in patients randomized initially to OAHT, mostly because of hypertension and proteinuria. There were no unexpected safety findings.ConclusionPatients randomized to LOW TAC with renin‐angiotensin system (RAS) blockade had similar outcomes at 5 years as patients treated with STD TAC with or without RAS blockade, whereas those randomized to LOW TAC without RAS blockade showed a non‐significant trend towards more rejections and dnDSATrial Registration:ClinicalTrials.gov identifier: NCT00933231 10.1111/ctr.70067 http://creativecommons.org/licenses/by-nc/4.0/ |
| doi_str_mv | 10.1111/ctr.70067 |
| format | Artículo Open Access |
| id | wiley_oa_10_1111_ctr_70067 |
| institution | Wiley Open Access |
| license_str_mv | http://creativecommons.org/licenses/by-nc/4.0/ |
| publishDate | 2024 |
| publisher | Wiley |
| record_format | wiley_oa |
| spellingShingle | A Five‐Year Prospective, Randomized, Open‐Label Study of Standard‐Dose Versus Low‐Dose Prolonged‐Release Tacrolimus With or Without Angiotensin‐Converting Enzyme Inhibitor or Angiotensin II Receptor Blocker Post Kidney Transplantation Patricia M. Campbell Marcelo Cantarovich Azim Gangji Isabelle Houde Anthony M. Jevnikar Felix‐Mauricio Monroy‐Cuadros Peter W. Nickerson Michel R. Pâquet G. V. Ramesh Prasad Lynne Senécal Jean‐Luc Wolff Jason J. Schwartz David N. Rush Clinical Transplantation A Five‐Year Prospective, Randomized, Open‐Label Study of Standard‐Dose Versus Low‐Dose Prolonged‐Release Tacrolimus With or Without Angiotensin‐Converting Enzyme Inhibitor or Angiotensin II Receptor Blocker Post Kidney Transplantation Patricia M. Campbell Marcelo Cantarovich Azim Gangji Isabelle Houde Anthony M. Jevnikar Felix‐Mauricio Monroy‐Cuadros Peter W. Nickerson Michel R. Pâquet G. V. Ramesh Prasad Lynne Senécal Jean‐Luc Wolff Jason J. Schwartz David N. Rush Clinical Transplantation ABSTRACTIntroductionNovel approaches to improve long‐term outcomes in kidney transplant recipients are required. Here, we present the 5‐year data from a multicenter, prospective, Phase 3b trial evaluating treatment outcomes with standard (STD) or low (LOW) dose prolonged‐release tacrolimus (TAC) combined with ACEi/ARB or other antihypertensive therapy (OAHT) in Canadian kidney transplant recipients.MethodsAdult de novo kidney transplant recipients were randomized 2 × 2 to STD or LOW dose TAC and ACEi/ARB or OAHT. Patients had received a first or second transplant from a living or deceased donor and had ≥ 1 human leukocyte antigen mismatch with their donor.ResultsThere were 281 patients from 13 sites across Canada. Overall patient survival was 95.7% and was comparable between groups. Graft survival at study end was 89.7% in the LOW+OAHT group and 94.4%–97.1% in the other groups and BPAR, and Class II de novo donor‐specific antibodies (dnDSA) were higher in the LOW+OAHT group than in the other groups. However, these differences were not statistically significant. Graft function, blood pressure (BP), and proteinuria were similar between the groups; however, between 2 and 5 years there was a 2‐fold or greater increase in the use of ACEi/ARB in patients randomized initially to OAHT, mostly because of hypertension and proteinuria. There were no unexpected safety findings.ConclusionPatients randomized to LOW TAC with renin‐angiotensin system (RAS) blockade had similar outcomes at 5 years as patients treated with STD TAC with or without RAS blockade, whereas those randomized to LOW TAC without RAS blockade showed a non‐significant trend towards more rejections and dnDSATrial Registration:ClinicalTrials.gov identifier: NCT00933231 10.1111/ctr.70067 http://creativecommons.org/licenses/by-nc/4.0/ |
| title | A Five‐Year Prospective, Randomized, Open‐Label Study of Standard‐Dose Versus Low‐Dose Prolonged‐Release Tacrolimus With or Without Angiotensin‐Converting Enzyme Inhibitor or Angiotensin II Receptor Blocker Post Kidney Transplantation |
| topic | Clinical Transplantation |
| url | https://onlinelibrary.wiley.com/doi/10.1111/ctr.70067 |