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Trial record 1 of 1 for:    Medeor NCT 03363945
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Cellular Immunotherapy in Recipients of HLA-matched, Living Donor Kidney Transplants

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ClinicalTrials.gov Identifier: NCT03363945
Recruitment Status : Recruiting
First Posted : December 6, 2017
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Medeor Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE November 30, 2017
First Posted Date  ICMJE December 6, 2017
Last Update Posted Date February 5, 2020
Actual Study Start Date  ICMJE March 15, 2018
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cellular Immunotherapy in Recipients of HLA-matched, Living Donor Kidney Transplants
Official Title  ICMJE 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
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Total lymphoid irradiation and anti-thymocyte globulin
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Kidney Transplant Rejection
Intervention  ICMJE Biological: MDR-101
Enriched CD34+ hematopoietic stem cells and defined dose of CD3+ T-cells
Study Arms  ICMJE
  • Active Comparator: MDR-101
    A single dose will be administered via IV infusion post-kidney transplant.
    Intervention: Biological: MDR-101
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 4, 2020)
30
Original Estimated Enrollment  ICMJE
 (submitted: November 30, 2017)
75
Estimated Study Completion Date  ICMJE January 2022
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lenuta Micsa, MD 646-239-9748 lmicsa@medeortx.com
Contact: Mercury Medeor 646-239-9748 mercury@medeortx.com
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03363945
Other Study ID Numbers  ICMJE MDR-101-MLK
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Medeor Therapeutics, Inc.
Study Sponsor  ICMJE Medeor Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Suzanne Crowley, MS, BSN Medeor Therapeutics
PRS Account Medeor Therapeutics, Inc.
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP