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

Use our guide to learn which trials are right for you!

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
27
sites
Cleveland, Ohio 44012
Phone: 216-844-5396
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
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...
?
mi
from
Boston, MA
Click here to add this to my saved trials
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...
?
mi
from
Boston, MA
Click here to add this to my saved trials
5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Phone: 773-702-6319
University of Chicago One of the world's premier academic and research institutions, the University of...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Sacramento, California 95814
Phone: 916-734-7977
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
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...
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Baltimore, Maryland 20742
(301) 405-1000
Phone: 410-328-8435
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
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...
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
Charlottesville, Virginia 22908
Phone: 215-615-0800
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
Columbus, Ohio 43210
Phone: 614-261-1141
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Detroit, Michigan 48202
Phone: 313-916-2711
?
mi
from
Detroit, MI
Click here to add this to my saved trials
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Phone: 919-613-6133
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
?
mi
from
Durham, NC
Click here to add this to my saved trials
Fairfax, Virginia 22031
Phone: 703-531-2246
?
mi
from
Fairfax, VA
Click here to add this to my saved trials
Houston, Texas 77030
Phone: 713-441-6174
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Kansas City, KS
Click here to add this to my saved trials
11234 Anderson St
Loma Linda, California 92354
(909) 558-4000
Phone: 909-558-3650
Loma Linda University Medical Center An outgrowth of the original Sanitarium on the hill in...
?
mi
from
Loma Linda, CA
Click here to add this to my saved trials
Madison, Wisconsin 53792
Phone: 312-908-2000
?
mi
from
Madison, WI
Click here to add this to my saved trials
Murray, Utah 84107
Phone: 801-507-8330
?
mi
from
Murray, UT
Click here to add this to my saved trials
New Haven, Connecticut 6520
(203) 432-4771
Phone: 203-785-6221
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
?
mi
from
New Haven, CT
Click here to add this to my saved trials
New York, New York 10029
Principal Investigator: Ron Shapiro, MD
Phone: 212-241-0255
?
mi
from
New York, NY
Click here to add this to my saved trials
New York, New York 10021
Phone: 212-746-8720
?
mi
from
New York, NY
Click here to add this to my saved trials
Orange, New Jersey 07052
Phone: 973-322-2146
?
mi
from
Orange, NJ
Click here to add this to my saved trials
1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Phone: 317-496-7944
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Rochester, Minnesota 55905
Phone: 507-266-2812
?
mi
from
Rochester, MN
Click here to add this to my saved trials
San Antonio, Texas 78229
Phone: 210-575-8400
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
Phone: 650-498-6189
Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
?
mi
from
Stanford, CA
Click here to add this to my saved trials
3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 687-7695
Georgetown University Medical Center Georgetown University Medical Center is committed to excellence in research, education...
?
mi
from
Washington,
Click here to add this to my saved trials