Cellular Immunotherapy 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.

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Key information

Conditions

Kidney Transplant Rejection

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CIUSSS de l'Est- de-l'Île-de-Montréal Installation Hopital Maisonneuve-Rosemont, Montreal, Quebec, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MDR-101

Biological

Enriched CD34+ hematopoietic stem cells and defined dose of CD3+ T-cells

Primary outcomes

Functional immune tolerance defined as

Time frame: Up to 36 months post-kidney transplant
- Achievement of the required duration of persistent donor mixed chimerism to permit calcineurin inhibitor immunosuppressive withdrawal beginning at 6-7 months post-kidney transplant surgery, and
- Successful withdrawal from all immunosuppressives by at least 12 months post-kidney transplant surgery, and
- Subsequent successful maintenance off all immunosuppressive drugs for at least 24 additional months (out to at least 36 months post-kidney transplant surgery) without biopsy-proven acute rejection, de novo Donor Specific Antibody, transplant kidney loss, or subject death. Loss to follow-up will be adjudicated as a failure in intent-to-treat analysis.

Sponsors and collaborators

Lead sponsor

Medeor Therapeutics, Inc.

Industry

Collaborators

California Institute for Regenerative Medicine (CIRM)

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2024
Study completion: 2024
First posted: Dec 6, 2017
Registry last updated: Jun 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed