Clinical Trial: Minimization of maintenance immunosuppression in kidney transplant recipients based on both T and B cell epitope analysis (Japan)

Tokyo, May 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061578) titled 'Minimization (optimization) of maintenance immunosuppression in kidney transplant recipients based on both T and B cell epitope analysis' on May 15.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -but assessor(s) are blinded Control - Active

Primary Sponsor: Institute - Aichi Medical University

Condition: Condition - Kidney transplantation Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Transplant recipients with favorable T cell epitope and B cell epitope compatibility (i.e., low eplet mismatch and PIRCHE score) were reported to have a significantly lower risk of immune responses leading to de novo DSA production. For such patients, we attempt to minimize and optimize immunosuppressive therapy. We confirm that no immune response is induced against the donor, specifically that no de novo DSA production is observed. For well-matched cases, we seek information on whether immunosuppressive therapy can be reduced. A large number of cases is required for the statistical analysis of a non-inferiority trial, therefore, this study will be conducted as a pilot trial. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - The study will enroll patients with a very low risk of an immune response leading to de novo DSA production and favorable T-cell and B-cell epitope compatibility (i.e., low eplet mismatch and low PIRCHE score). Patients will be randomized to Reduction Group or Control (Maintenance) Group. In Reduction Group, we will attempt to minimize maintenance immunosuppressive therapy, that is, calcineurin inhibitor (tacrolimus or cyclosporine) will be reduced by one-third to one-half. Interventions/Control_2 - The study will enroll patients with a very low risk of an immune response leading to de novo DSA production and favorable T-cell and B-cell epitope compatibility (i.e., low eplet mismatch and low PIRCHE score). Patients will be randomized to Reduction Group or Control (Maintenance) Group. In Control Group (maintenance group), immunosuppressive therapy will remain unchanged.

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - 1 to 10 years post-transplant Transplants performed in 2016 or later Stable transplant kidney function (no change in transplant kidney function over the past 6 months) Low B cell epitope mismatch (eplet MM (ver.3.1 antibody verified for DRB, DQB and DQA) is 4 or less) and low T cell epitope mismatch (PIRCHE-II score is 175 or less) Key exclusion criteria - History of rejection episode Sibling HLA haplotype identity (case of complete HLA haplotype match between siblings) Donor specific HLA antibody (DSA)-positive transplantation de novo DSA production Target Size - 100

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 04 Month 06 Day Anticipated trial start date - 2026 Year 05 Month 01 Day Last follow-up date - 2030 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069665

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