Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 compatibility 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Total lymphoid irradiation and anti-thymocyte globulin
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
MDR-101
A single dose will be administered via IV infusion post-kidney transplant.
  • Drug: MDR-101
    Enriched CD34+ hematopoietic stem cells and defined dose of CD3+ T-cells
No Intervention
Control Arm
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.

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37232
Contact:
Douglas Hale, MD
615-936-0404
douglas.a.hale@vanderbilt.edu

More Details

NCT ID
NCT03363945
Status
Recruiting
Sponsor
Medeor Therapeutics, Inc.

Study Contact

Medeor Therapeutics
1-855-228-7515
mercury@medeortx.com

Detailed Description

Currently, patients receiving a transplanted kidney are required to take life-long immunosuppressive medications to prevent rejection of the transplanted kidney. These medications carry substantial side effects. In addition, these medicines often do not completely control damage to the kidney from the recipients' immune system, ultimately causing the kidney to fail.

Medeor Therapeutics is developing a novel cell-based therapy to reprogram the recipients' immune system to accept a transplanted kidney without the need for long term use of immunosuppression drugs.

The purpose of the current Phase 3 study is to demonstrate the efficacy and safety of MDR-101 for the induction of transplant immune tolerance in a prospective, randomized, multicenter clinical trial. MDR-101 is intended to induce mixed lymphohematopoietic chimerism and donor specific immune tolerance in order to preserve transplant kidney function, avert transplant kidney rejection, and eliminate the cumulative and serious side effects associated with immunosuppressive drugs.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.