For Healthcare Professionals

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

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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.
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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

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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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