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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03363945
Recruitment Status : Recruiting
First Posted : December 6, 2017
Last Update Posted : August 2, 2018
Information provided by (Responsible Party):
Medeor Therapeutics, Inc.

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.

Condition or disease Intervention/treatment Phase
Kidney Transplant Rejection Drug: MDR-101 Phase 3

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Total lymphoid irradiation and anti-thymocyte globulin
Masking: None (Open Label)
Primary Purpose: Prevention
Official 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
Actual Study Start Date : March 15, 2018
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Recipient Inclusion Criteria:

  • Planned recipient of a first kidney allograft from an HLA-matched, living related donor
  • Age ≥18 and ≤65 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) relative of the prospective recipient participant
  • Age ≥18 and ≤65 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
  • History of infection with Zika virus

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03363945

Contact: Nancy Wu, MBA 415-999-3550
Contact: David Tsai 415-580-1483

United States, California
UC Davis Medical Center Recruiting
Sacramento, California, United States, 95817
Contact: Junichiro Sageshima, MD    916-734-7977   
Contact: Katrina Falwell    (916) 453-2134   
Stanford University Medical Center Recruiting
Stanford, California, United States, 94305
Contact: Stephan Busque, MD    650-498-6189   
Contact: Asha Shori    650-736-0245   
United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Alexander Wiseman, MD    720-848-2237   
Contact: Janis Cicerchi    303-724-0183   
United States, Illinois
The University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Piotr Witkowski, MD    773-702-6319   
Contact: Lindsay Basto    773-702-2504   
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: David Bruno, MD    410-328-8435   
Contact: Amanda Bartosic    (410) 328-1321   
United States, Massachusetts
Brigham & Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Anil Chandraker, MD    617-732-5259   
Contact: Sarah Conte    617-525-8003   
Principal Investigator: Anil Chandraker, MD         
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Susan McDermott, RN    617-632-9841   
Contact: Catherine Helzer    617-632-9919   
United States, Michigan
Henry Ford Recruiting
Detroit, Michigan, United States, 48202
Contact: Anita Patel, MD    313-916-2711   
Contact: Catherine Crombez    313-916-0692   
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Mark Stegall, MD    507-266-2812   
Contact: Nong Braaten    507-538-9617   
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Kadiyala Ravindra, MD    919-613-6133   
Contact: Miranda West    (919) 681-5557   
United States, Ohio
University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Kenneth Chavin, MD    216-844-5396   
Contact: Tricia Young    (216) 844-5396   
Ohio State University Medical Group Recruiting
Columbus, Ohio, United States, 43210
Contact: Amer Rajab, MD    614-261-1141   
Contact: Brittany Holloway    614-293-4665   
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Ashesh Shah, MD    317-496-7944   
Contact: Dee Rinaldi    215-503-1765   
United States, Texas
The Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Ahmed Gaber, MD    713-441-6174   
Contact: Darrel Cleere    713-441-6232   
Methodist Healthcare System Recruiting
San Antonio, Texas, United States, 78229
Contact: Adam Bingaman, MD    210-575-8400   
Contact: Gloria Carreon    210-575-4238   
United States, Utah
Intermountain Transplant Center Recruiting
Murray, Utah, United States, 84107
Contact: Titte Srinivas, MD    801-507-8330   
Contact: Jake Krong    801-507-9333   
United States, Virginia
University Of Virginia Hospital Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Kenneth Brayman, MD    215-615-0800   
Contact: Matthew Kime    434-924-5529   
INOVA Fairfax Hospital Recruiting
Fairfax, Virginia, United States, 22031
Contact: James Piper, MD    703-531-2246   
Contact: Mallory Frazier    202-841-0498   
United States, Wisconsin
University of Wisconsin School of Medicine Recruiting
Madison, Wisconsin, United States, 53792
Contact: Dixon B Kaufman, MD    312-908-2000   
Contact: Kristi Schneider, RN MSN ANP    608-263-7064   
Sponsors and Collaborators
Medeor Therapeutics, Inc.
Study Director: D. Scott Batty, Jr., MD Medeor Therapeutics

Responsible Party: Medeor Therapeutics, Inc. Identifier: NCT03363945     History of Changes
Other Study ID Numbers: MDR-101-MLK
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by Medeor Therapeutics, Inc.:
kidney transplant
cellular therapy
anti-rejection therapy
living donor
hematopoietic stem cells (HSC)
T cells