Kidney Transplant Rejection Clinical Trial
Official title:
A Phase 3, Randomized, Multi-center, Open-label, Controlled Trial to Assess the Efficacy and Safety of Cellular Immunotherapy With MDR-101 for Induction of Immune Tolerance in Recipients of HLA-matched, Living Donor Kidney Transplants
The primary objective of this study is to demonstrate the safety and efficacy of cellular immunotherapy with MDR-101 for induction of functional immune tolerance in recipients of human leukocyte antigen (HLA)-matched, living donor kidney transplants.
Currently, patients receiving a transplanted kidney are required to take life-long immunosuppressive medications to prevent rejection of the transplanted kidney. These medications carry substantial side effects. In addition, these medicines often do not completely control damage to the kidney from the recipients' immune system, ultimately causing the kidney to fail. Medeor Therapeutics is developing a novel cell-based therapy to reprogram the recipients' immune system to accept a transplanted kidney without the need for long term use of immunosuppression drugs. The purpose of the current Phase 3 study is to demonstrate the efficacy and safety of MDR-101 for the induction of transplant immune tolerance in a prospective, randomized, multicenter clinical trial. MDR-101 is intended to induce mixed lymphohematopoietic chimerism and donor specific immune tolerance in order to preserve transplant kidney function, avert transplant kidney rejection, and eliminate the cumulative and serious side effects associated with immunosuppressive drugs. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04491552 -
TruGraf® Long-term Clinical Outcomes Study
|
||
| Withdrawn |
NCT04560582 -
Immunosuppression Reduction in Failed Allograft Guided by cfDNA
|
||
| Completed |
NCT05747274 -
SRDK0921_ Analytical Performance Study
|
||
| Not yet recruiting |
NCT05482100 -
CLinical Utility of the omnigrAf® biomarkeR Panel In The Care of kidneY Transplant Recipients
|
||
| Recruiting |
NCT06243289 -
Improving KIdney Transplantation With Cellular Therapy Study
|
||
| Not yet recruiting |
NCT06025240 -
Expanding the Scope of Post-transplant HLA-specific Antibody Detection and Monitoring in Renal Transplant Recipients
|
||
| Completed |
NCT04367610 -
Effects of A Standardized Treatment Approach on Kidney Transplant Recipients With Antibody-Mediated Rejection
|
||
| Enrolling by invitation |
NCT06126380 -
Long-Term Safety and Efficacy of Tegoprubart in Kidney Transplant Recipients
|
Phase 2 | |
| Terminated |
NCT05747053 -
Personalization of Immunosuppressive Treatment for Organ Transplant Recipients
|
||
| Active, not recruiting |
NCT03714113 -
Donor-specific Anti-HLA Antibodies Monitoring in Kidney Transplant Recipients
|
N/A | |
| Recruiting |
NCT04091984 -
The PROspera Kidney Transplant ACTIVE Rejection Assessment Registry (ProActive)
|
||
| Recruiting |
NCT05335538 -
TruGraf and TRAC In Pediatrics Study
|
||
| Completed |
NCT03663335 -
Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant Recipients
|
Phase 2 | |
| Completed |
NCT03652402 -
Precision Risk Stratification in Kidney Transplant Patients - EU-TRAIN
|
||
| Recruiting |
NCT04773392 -
Simplified IMmunosuppressive Protocol Utilizing Low Dose EnvarsusXR
|
Phase 4 | |
| Terminated |
NCT02974686 -
Conversion From MPA to Zortress (Everolimus) for GI Toxicity Post-renal Transplantation
|
Phase 4 | |
| Completed |
NCT03873623 -
The TOGETHER Project - Kidney
|
||
| Terminated |
NCT04156204 -
Immunosuppressant Medication Dosed Daily After Kidney Transplant
|
Early Phase 1 | |
| Completed |
NCT04601155 -
Transition of Renal Patients Using AlloSure Into Community Kidney Care
|
||
| Completed |
NCT03874299 -
The TOGETHER Project - Kidney RNA-seq Validation
|