Cellular Immunotherapy in Recipients of HLA-matched, Living Donor Kidney Transplants

clipboard-pencil

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.
user-3

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Recipient Inclusion Criteria:


  1. Planned recipient of a first kidney allograft from an HLA-matched, living related donor
  2. Age ≥18 and ≤70 years
  3. Single solid organ recipient (kidney only)
  4. ABO matched with donor

Donor Inclusion Criteria:


  1. HLA-matched first degree (parent, child or sibling) or second-degree (child of a sibling or half sibling) relative of the prospective recipient participant
  2. Age ≥18 and ≤70 years
  3. 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:


  1. Underlying kidney disease with a high risk of disease recurrence in the transplanted kidney
  2. Baseline positive donor-specific anti-HLA antibody testing
  3. Is taking immunosuppressive therapy
  4. Evidence of prior hepatitis B (HBV) or hepatitis C (HCV)

Donor Exclusion Criteria:


  1. History of autoimmune disorders
  2. History of type 1 or type 2 diabetes mellitus
  3. Tests confirmed positive for human immunodeficiency virus (HIV), HBV, HCV, T. cruzi, or syphilis
  4. History of infection with Zika virus

pin location

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

Understanding Clinical Trials


Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?
Vector

Interested?

Sign up to save your favorites, 
receive newsletters, resources, and alerts 
about clinical trials related to your conditions of interest.