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



Status:Recruiting
Healthy:No
Age Range:18 - 65
Updated:1/30/2019
Start Date:March 15, 2018
End Date:January 2022
Contact:Medeor Therapeutics
Email:mercury@medeortx.com
Phone:1-855-228-7515

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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

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.

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.

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
We found this trial at
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Chapel Hill, North Carolina 27599
(919) 962-2211
Phone: 919-966-8008
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Phone: 617-632-9841
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Anil Chandraker, MD
Phone: 617-732-5259
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Phone: 773-702-6319
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Sacramento, California 95814
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13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
Phone: 720-848-2237
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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Baltimore, Maryland 20742
(301) 405-1000
Phone: 410-328-8435
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Charlottesville, Virginia 22908
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Cleveland, Ohio 44012
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Columbus, Ohio 43210
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Detroit, Michigan 48202
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
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Fairfax, Virginia 22031
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Houston, Texas 77030
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11234 Anderson St
Loma Linda, California 92354
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Madison, Wisconsin 53792
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New Haven, Connecticut 6520
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Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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New York, New York 10029
Principal Investigator: Ron Shapiro, MD
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New York, New York 10021
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Orange, New Jersey 07052
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1020 Walnut St
Philadelphia, Pennsylvania 19107
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300 Pasteur Dr
Stanford, California 94305
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Washington, District of Columbia 20007
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