✓ Translated by DotMD AI Clinical Council Source: Journal of the American Society of Nephrology : JASN • Phase III Randomized Trial
Verify Primary Source: NIH PubMed PMID #34706967 ↗

Phase III Randomized Trial: Conversion from Calcineurin Inhibitor- to Belatacept-Based Maintenance Immunosuppression in Renal Transplant Recipients (N = 223)

Original Paper Title: “Conversion from Calcineurin Inhibitor- to Belatacept-Based Maintenance Immunosuppression in Renal Transplant Recipients: A Randomized Phase 3b Trial”

Elena Rostova (AI Quant) Rigor Score
82 / 100
Sample Size (Participants)
N = 223
Evidence Classification
Phase III Randomized Trial
Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways
  • Switching stable renal transplant recipients from CNI-based to belatacept-based immunosuppression was associated with a similar rate of death or graft loss, improved renal function, and a numerically higher BPAR rate but a lower incidence of dnDSA.Clinical Trial registry name and registration number: A Study in Maintenance Kidney Transpla.
  • Study Design & Sample: Phase III Randomized Trial published in Journal of the American Society of Nephrology : JASN (N = 223 human participants).
  • Biostatistical Rigor Score: 82/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in Journal of the American Society of Nephrology : JASN (2021), this phase iii randomized trial evaluating 223 human participants investigated: Calcineurin inhibitors (CNIs) are standard of care after kidney transplantation, but they are associated with nephrotoxicity and reduced long-term graft survival. Key clinical takeaway: Switching stable renal transplant recipients from CNI-based to belatacept-based immunosuppression was associated with a similar rate of death or graft loss, improved renal function, and a numerically higher BPAR rate but a lower incidence of dnDSA.Clinical Trial registry name and registration number: A Study in Maintenance Kidney...

Dr. Lin (AI Evidence Lead): Statistical Endpoints & Numbers

Primary Endpoint & Quantitative Summary (Journal of the American Society of Nephrology : JASN, 2021-12-01; N = 223; Rigor 82/100): Switching stable renal transplant recipients from CNI-based to belatacept-based immunosuppression was associated with a similar rate of death or graft loss, improved renal function, and a numerically higher BPAR rate but a lower incidence of dnDSA.Clinical Trial registry name and registration number: A Study in Maintenance Kidney Transpla.

Study Limitations & Caveats Before You Act

Clinical trials evaluate specific inclusion/exclusion cohorts under protocol-controlled conditions (Phase III Randomized Trial). Individual response, hepatic/renal clearance, CYP450 drug interactions, and baseline comorbidities vary; verify applicability with a board-certified physician before modifying any prescription or supplement regimen.

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