NCT03363945
Cellular Immunotherapy in Recipients of HLA-matched, Living Donor Kidney Transplants
PHASE3
ACTIVE_NOT_RECRUITING
NCT03363945
INTERVENTIONAL
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.
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 disease recurrence in the transplanted kidney
* Baseline positive donor-specific anti-HLA antibody testing
* Is taking immunosuppressive therapy
* Evidence of prior hepatitis B (HBV) or hepatitis C (HCV)
Donor Inclusion Criteria:
* HLA-matched first degree (parent, child or sibling) or second-degree (child of a sibling or half sibling) relative of the prospective recipient participant
* Age ≥18 and ≤70 years
* Prepared to be a living related kidney donor, and capable of undergoing G-CSF mobilization and apheresis of hematopoietic cells
Donor Exclusion Criteria:
* History of autoimmune disorders
* History of type 1 or type 2 diabetes mellitus
* Tests confirmed positive for human immunodeficiency virus (HIV), HBV, HCV, T. cruzi, or syphilis
* History of infection with Zika virus
Kidney Transplant Rejection
- PREVENTION
-
- Type: BIOLOGICAL
- Name: MDR-101
- Description: Enriched CD34+ hematopoietic stem cells and defined dose of CD3+ T-cells
- Arm Group Labels: MDR-101
- Medeor Therapeutics, Inc.