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

NCT00497926 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: FCR001A2201
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

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.

Conditions

Kidney Failure

Keywords

Kidney transplant; Tolerance; Marrow/Enriched Hematopoietic Stem Cell Transplant

Outcome Measures

Primary Outcomes (1)

• Enriched Hematopoietic Stem Cell Engraftment

  One month to three years

Study Arms (1)

Living Kidney Allograft

EXPERIMENTAL

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

Interventions

Enriched Hematopoietic Stem Cell Infusion BIOLOGICAL

Enriched Hematopoietic Stem Cell Infusion

Living Kidney Allograft

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Talaris Therapeutics Inc.: lead
• Northwestern University: collaborator
• Regenerex, LLC: collaborator
• Duke University: collaborator

Study Sites (2)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Related Publications (3)

• Leventhal JR, Galvin J, Ison MG, Feng CY, Ding R, Lee JR, Li C, Mathew JM, Gallon L, Gibson M, Belshe D, Tollerud DJ, Gornstein E, Suthanthiran M, Ildstad ST. Evaluation of Immunocompetence and Biomarkers of Tolerance in Chimeric and Immunosuppression-free Kidney Allograft Recipients. Transplantation. 2023 Oct 1;107(10):e257-e268. doi: 10.1097/TP.0000000000004666. Epub 2023 Sep 25.

  PMID: 37370204 DERIVED

• 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.

  PMID: 29191961 DERIVED

• 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.

  PMID: 25594553 DERIVED

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Ken Abrams, MD

  Talaris Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2007
• First Posted: July 9, 2007
• Study Start: March 1, 2008
• Primary Completion: March 1, 2023
• Study Completion: April 1, 2023
• Last Updated: October 11, 2023

Record last verified: 2023-10

Locations

US (2)