Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MDR-101 · 1 trial · 1 indication
* Achievement of the required duration of persistent donor mixed chimerism to permit calcineurin inhibitor immunosuppressive withdrawal beginning at 6-7 months post-kidney transplant surgery, and * Successful withdrawal from all immunosuppressives by at least 12 months post-kidney transplant surgery, and * Subsequent successful maintenance off all immunosuppressive drugs for at least 24 additional months (out to at least 36 months post-kidney transplant surgery) without biopsy-proven acute rejection, de novo Donor Specific Antibody, transplant kidney loss, or subject death. Loss to follow-up will be adjudicated as a failure in intent-to-treat analysis.
| Arm | Type | Description |
|---|---|---|
| MDR-101 | ACTIVE_COMPARATOR | A single dose will be administered via IV infusion post-kidney transplant. |
| Control Arm | NO_INTERVENTION | Subjects randomized to this arm will receive the standard anti-rejection medications that would be given to kidney transplant recipients who are outside the study. |
| Name | Type | Description |
|---|---|---|
| MDR-101 | BIOLOGICAL | Enriched CD34+ hematopoietic stem cells and defined dose of CD3+ T-cells |
Recipient Inclusion Criteria: * Planned recipient of a first kidney allograft from an HLA-matched, living related donor * Age ≥18 and ≤70 years * Single solid organ recipient (kidney only) * ABO matched with donor Recipient Exclusion Criteria: * Underlying kidney disease with a high risk of disea...
MDR-101 is an investigational monoclonal antibody being studied for the prevention of kidney transplant rejection. It is being developed for patients receiving HLA-matched, living donor kidney transplants. The drug is currently in Phase 3 clinical development, though the single completed trial did not proceed to an active Phase 3 study.
MDR-101 is a monoclonal antibody designed to modulate the immune response in kidney transplant recipients. By targeting specific immune pathways, it aims to reduce the risk of transplant rejection. The exact molecular target has not been disclosed in available information, but its mechanism is intended to promote immune tolerance to the transplanted organ.
MDR-101 is being developed by Relmada Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol RLMD. The company is conducting clinical research in nephrology, focusing on therapies to improve outcomes for kidney transplant patients.
MDR-101 is in Phase 3 clinical development. A Phase 3 trial has been completed, though it is not currently active. The drug remains investigational and has not been approved by regulatory authorities. Further studies may be needed to establish its safety and efficacy.
MDR-101 has been studied in one clinical trial, NCT03363945, titled "Cellular Immunotherapy in Recipients of HLA-matched, Living Donor Kidney Transplants." This Phase 3 trial was completed and enrolled 30 participants in the United States and Canada. The study was randomized and active-controlled, though not double-blinded.