drugset
drugset / Trial / NCT05145296

The Safety/Efficacy Of Daratumumab With Belatacept In Highly HLA-Sensitized Patients Awaiting Kidney Transplantation

NCT05145296 ↗

Phase 2 Terminated 5 enrolled University Hospital, Grenoble Bristol-Myers Squibb · collab
NaSingle-groupOpen-labelTreatment

Summary

While the number of kidney transplants is increasing worldwide every year, there is a clear imbalance between the high number of patients in the waiting list and those receiving a transplant and importantly, among waitlist patients there is a progressively higher number of highly sensitised patients that have very low or even no chance to receive a compatible organ. These patients remain for very long periods of time on dialysis therapy, having lower quality of life, lower life expectancy and produce higher health-related costs. Unfortunately, current desensitization therapies have shown very poor success and patients usually lose these grafts very fast if transplanted across a positive cross-match. Therefore, there is an urgent need for novel desensitization strategies capable of overcoming this immunological barrier and allow an increasing number of patients to receive a HLA-compatible kidney allograft.This is a non-randomized, single arm study, combination trial designed according to the Recommendations of the Clinical Trial Design Task Force of the NCI Investigational Drug Steering Committee. The study will enroll 12 patients with cPRA or TGI ≥99% on the deceased donor kidney transplant waiting list, who have not received a compatible donor offer for \>3 year. According to inclusion and exclusion criteria patients will be screened to participate in the trial.

Timeline

Start
2022-01-19
Primary completion
2024-12-01
Completion
2025-10-10

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Belatacept Protein / enzyme biologic 5 mg/kg —
Subject Daratumumab Monoclonal antibody 8 mg/kg —

Indications

anti-HLA hyperimmunization