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

Primary Purpose

Kidney Failure

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Enriched Hematopoietic Stem Cell Infusion
Sponsored by
Talaris Therapeutics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Failure focused on measuring Kidney transplant, Tolerance, Marrow/Enriched Hematopoietic Stem Cell Transplant

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Northwestern Memorial Hospital
  • Duke University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Living Kidney Allograft

Arm Description

Recipients with the need for a living kidney allograft are treated with an enriched hematopoietic stem cell infusion from the same living donor

Outcomes

Primary Outcome Measures

Enriched Hematopoietic Stem Cell Engraftment

Secondary Outcome Measures

Full Information

First Posted
July 6, 2007
Last Updated
October 10, 2023
Sponsor
Talaris Therapeutics Inc.
Collaborators
Northwestern University, Regenerex, LLC, Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT00497926
Brief Title
Induction of Donor Specific Tolerance in Recipients of Living Kidney Allografts by Donor FCRx Infusion
Official Title
Induction of Donor Specific Tolerance in Recipients of Living Kidney Allografts by Donor FCRx Infusion
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Terminated
Why Stopped
living donor kidney program terminated due to slow pace of phase 3 study enrollment
Study Start Date
March 2008 (Actual)
Primary Completion Date
March 2023 (Actual)
Study Completion Date
April 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Talaris Therapeutics Inc.
Collaborators
Northwestern University, Regenerex, LLC, Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure
Keywords
Kidney transplant, Tolerance, Marrow/Enriched Hematopoietic Stem Cell Transplant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Living Kidney Allograft
Arm Type
Experimental
Arm Description
Recipients with the need for a living kidney allograft are treated with an enriched hematopoietic stem cell infusion from the same living donor
Intervention Type
Biological
Intervention Name(s)
Enriched Hematopoietic Stem Cell Infusion
Intervention Description
Enriched Hematopoietic Stem Cell Infusion
Primary Outcome Measure Information:
Title
Enriched Hematopoietic Stem Cell Engraftment
Time Frame
One month to three years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ken Abrams, MD
Organizational Affiliation
Talaris Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29191961
Citation
Gallon L, Mathew JM, Bontha SV, Dumur CI, Dalal P, Nadimpalli L, Maluf DG, Shetty AA, Ildstad ST, Leventhal JR, Mas VR. Intragraft Molecular Pathways Associated with Tolerance Induction in Renal Transplantation. J Am Soc Nephrol. 2018 Feb;29(2):423-433. doi: 10.1681/ASN.2017030348. Epub 2017 Nov 30.
Results Reference
derived
PubMed Identifier
25594553
Citation
Leventhal JR, Elliott MJ, Yolcu ES, Bozulic LD, Tollerud DJ, Mathew JM, Konieczna I, Ison MG, Galvin J, Mehta J, Badder MD, Abecassis MM, Miller J, Gallon L, Ildstad ST. Immune reconstitution/immunocompetence in recipients of kidney plus hematopoietic stem/facilitating cell transplants. Transplantation. 2015 Feb;99(2):288-98. doi: 10.1097/TP.0000000000000605.
Results Reference
derived

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

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