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Induction of Donor Specific Tolerance in Recipients of Living Kidney Allografts by Donor FCRx Infusion

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00497926
Recruitment Status : Terminated (living donor kidney program terminated due to slow pace of phase 3 study enrollment)
First Posted : July 9, 2007
Last Update Posted : May 6, 2023
Sponsor:
Collaborators:
Northwestern University
Regenerex, LLC
Duke University
Information provided by (Responsible Party):
Talaris Therapeutics Inc.

Study Description
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Brief Summary:
An open-label study to assess the safety, efficacy, and tolerance of FCRx cell therapy in adult recipients within 12 months after kidney transplantation from a living donor.

Condition or disease Intervention/treatment Phase
Kidney Failure Biological: Enriched Hematopoietic Stem Cell Infusion Phase 2

Detailed Description:
Research study which involves the use of a combination of an Enriched Hematopoietic Stem Cell Infusion (stem cells, produced by the bone marrow, generate the cells that form the blood elements, help fight infection and assist in clotting) and kidney transplantation from the same donor to try to avoid the need for long-term anti-rejection drug therapy. The desired result of this study is to allow the body to develop "tolerance" to the transplanted kidney. Tolerance means that the body would see the transplanted kidney as part of the patient and not try to get rid of, or reject it. To prevent rejection, drugs called immunosuppressive agents must be taken on a daily basis. The purpose of this study is to determine if this procedure is safe and to try to substantially reduce or even eliminate the need for anti-rejection medications.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Induction of Donor Specific Tolerance in Recipients of Living Kidney Allografts by Donor FCRx Infusion
Actual Study Start Date : March 2008
Actual Primary Completion Date : March 2023
Actual Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Organ Donation

Arms and Interventions
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Arm Intervention/treatment
Experimental: Living Kidney Allograft
Recipients with the need for a living kidney allograft are treated with an enriched hematopoietic stem cell infusion from the same living donor
 Biological: Enriched Hematopoietic Stem Cell Infusion
Enriched Hematopoietic Stem Cell Infusion


Outcome Measures
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Primary Outcome Measures :
  1. Enriched Hematopoietic Stem Cell Engraftment [ Time Frame: One month to three years ]

Eligibility Criteria
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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
Criteria

Inclusion Criteria:

  • Patient must be between the ages of 18 and 65 years and meet the institution's criteria for renal transplantation for end-organ failure
  • Meets the transplant criteria by the study site and both the recipient and donor have been accepted as candidates for standard of care living kidney donation and transplantation
  • Patient is receiving a renal transplant only
  • The crossmatch is negative between donor and recipient. An initial crossmatch will be performed prior to stem cell mobilization to determine if subject can proceed with the apheresis.
  • Potential recipients who are women of child bearing potential must have a negative pregnancy test (urine test is acceptable) within 48 hours prior to receiving Granulocyte colony-stimulating factor (G-CSF) and agree to use reliable contraception for 1 year following FCRx infusion
  • Potential donors who are women of child bearing potential must have a negative pregnancy test (urine test is acceptable) within 48 hours prior to receiving G-CSF
  • No evidence of donor-specific antibody presently or historically
  • Panel Reactive Antibody (PRA) less than or equal to 20

Note: The subjects do not need to be local residents in order to be eligible for this trial, but must be willing to reside in the area, or within a four-hour drive, for the first month of the protocol so that they can be monitored closely in the early post-transplant period.

Exclusion Criteria:

  • Clinically active bacterial, fungal, viral or parasitic infection
  • Pregnancy
  • Clinical or serologic evidence of viral infection which would preclude the recipient from receiving a kidney transplant or FCRx infusion
  • Previous radiation therapy at a dose which would preclude Total Body Irradiation (TBI)
  • Positive crossmatch between donor and recipient
  • Evidence for immunologic memory against donor
  • Body Mass Index (BMI) >35 or <18
  • Positive serologies for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), human immunodeficiency virus (HIV)
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00497926


Locations
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United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Talaris Therapeutics Inc.
Northwestern University
Regenerex, LLC
Duke University
Investigators
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Study Director: Ken Abrams, MD Talaris Therapeutics
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Talaris Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT00497926    
Other Study ID Numbers: FCR001A2201
First Posted: July 9, 2007    Key Record Dates
Last Update Posted: May 6, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Talaris Therapeutics Inc.:
Kidney transplant
Tolerance
Marrow/Enriched Hematopoietic Stem Cell Transplant
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases
Female Urogenital Diseases
 Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases