Kidney Transplant clinical trials at UCSF

The purpose of this study is to evaluate the safety and efficacy of TCD601 in combination with Belatacept when compared to standard of care immunosuppression therapy in de novo renal transplant patients.

The purpose of this study is to determine the optimal regimen for the use of siplizumab, a human anti-CD2 antibody, combined with donor bone marrow cells and non-myeloablative conditioning, for tolerance induction in living donor renal transplantation

Primary Objectives: - Cohort A: To evaluate the efficacy of BIVV020 in prevention of AMR - Cohort B: To evaluate the efficacy of BIVV020 in treatment of active AMR Secondary Objectives: - To assess the overall efficacy of BIVV020 in prevention or treatment of AMR - To characterize the safety and tolerability of BIVV020 in kidney transplant participants - To characterize the pharmacokinetic (PK) profile of BIVV020 in kidney transplant participants - To evaluate the immunogenicity of BIVV020

An open label, non-randomized pilot study in kidney transplant recipients who received a completed primary series and bivalent booster of mRNA based COVID-19 vaccine and have =<2500 U/mL SARS-CoV-2 S antibody concentration using the Roche Elecsys(R) anti-RBD assay. Up to 80 participants will be enrolled in this study. Eligible participants will receive a dose of the Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccine candidate.. The primary objective is to determine whether a booster dose of the Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccine will elicit an increased SARS-CoV-2 antibody response in participants who have failed to maintain an antibody titer >2500 U/mL (using the Roche Elecsys(R) anti-RBD assay) to 2 or more doses of mRNA based COVID-19 vaccine

The primary objective of this study is to demonstrate the efficacy of ravulizumab vs placebo in reducing the severity of DGF as measured by time to freedom from dialysis in adult participants who are at high risk of DGF after undergoing transplant of deceased donor kidney.

This is a prospective, randomized multicenter trial of preemptive therapy (PET) vs. antiviral prophylaxis (AP) for prevention of cytomegalovirus (CMV) disease in adult D+R- kidney transplant recipients (KTR). Patients meeting study eligibility criteria and who have provided informed consent will be randomized (1:1) within 7 days of transplant to receive, in an open label design, either AP with valganciclovir 900 mg orally once daily or letermovir 480 mg orally once daily [both dose adjusted per Food and Drug Administration (FDA) label] for 200 days post-transplant), or PET (central lab weekly plasma polymerase chain reaction (PCR) monitoring for CMV deoxyribonucleic acidemia (DNAemia)) for 100 days post-transplant, with oral valganciclovir 900mg orally twice daily (or renally dosed per FDA label) at onset of CMV DNAemia at any level and continued until plasma CMV DNAemia is negative or below the level of quantitation in two consecutive weekly plasma samples. Study participants will be followed for pre-specified outcomes (clinical, laboratory, immunologic, safety) until withdrawal, death, or study closure, up to a maximum of 5.5 years post-transplant. Approximately 360 participants (180 participants in each group) will be randomized into the study. Estimated Time to Complete Enrollment: 4 years

This research is being done to better understand rejection in transplant recipients with HIV who receive kidneys from donors with vs without HIV.

This phase II trial studies whether the nonavalent human papillomavirus vaccine given to adults prior to kidney transplantation can help the body build and maintain an effective immune response during the post-transplant period when they receive immunosuppressive drugs to prevent transplant rejection. This study will help inform our scientific understanding about vaccine-induced immune responses among immunosuppressed individuals.

An open-label, controlled, randomized Phase 3 trial evaluating 12-month kidney function in highly sensitized (cPRA ≥99.9%) kidney transplant patients with positive crossmatch against a deceased donor, comparing desensitization using imlifidase with standard of care

This study will evaluate the safety and efficacy of AT-1501 compared with tacrolimus in patients undergoing kidney transplantation.

The objective of the proposed pilot trial is to determine the feasibility and safety of increasing watermelon consumption, with or without coenzyme Q supplementation in patients after kidney transplantation on kidney function and urinary protein excretion.

Accurately predicting kidney recipient risk of death has a crucial interest because of the organ shortage, the need to optimize allograft allocation by identifying high-risk patients who may not benefit from a transplant and improve the clinical decision-making after transplant to ensure that each patient survives as long as possible. However, according to a literature review the investigators performed, studies attempting to develop a kidney recipient death prediction model suffer from many shortcomings, including the lack of key risk factors, use of biased registry data, small sample size, lack of external validation in different countries and subpopulations, and short follow-up. The present study thus aimed to address these limitations and develop a robust, generalizable kidney recipient death prediction model.