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

• Sponsor: Talaris Therapeutics Inc. (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT00497926
• Collaborator: Northwestern University (Other), Regenerex, LLC (Other), Duke University (Other)
• Enrollment: 60
• Locations: 2
• Arm: 1
• Duration (Months): 276
• Patients Per Site: 30
• Patients Per Site Per Month: 0.1

Study Details

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.

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

• Study Type: Interventional
• Anticipated 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
• Study Start Date: Mar 1, 2008
• Anticipated Primary Completion Date: Mar 1, 2026
• Anticipated Study Completion Date: Mar 1, 2031

Arms and Interventions

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

Primary Outcome Measures

1. Enriched Hematopoietic Stem Cell Engraftment [One month to three years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Northwestern Memorial Hospital	Chicago	Illinois	United States	60611
2	Duke University	Durham	North Carolina	United States	27710

Sponsors and Collaborators

• Talaris Therapeutics Inc.
• Northwestern University
• Regenerex, LLC
• Duke University

Investigators

• Study Director: Ken Abrams, MD, Talaris Therapeutics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Talaris Therapeutics Inc.
• ClinicalTrials.gov Identifier: NCT00497926
• Other Study ID Numbers: FCR001A2201
• First Posted: Jul 9, 2007
• Last Update Posted: Jul 18, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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: Renal Insufficiency

Study Results

No Results Posted as of Jul 18, 2022