Cellular Immunotherapy in Recipients of HLA-matched, Living Donor Kidney Transplants
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
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
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
EXCLUSION CRITERIA
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 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
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Kidney Transplant Rejection
Age (in years)
18 - 70
Phase
Phase 3
Participants needed
30
Est. Completion Date
Sep 30, 2024
Treatment type
Interventional
Sponsor
Medeor Therapeutics, Inc.
ClinicalTrials.gov identifier
NCT03363945
Study number
MDR-101-MLK
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