TLI, TBI, ATG & Hematopoietic Stem Cell Transplantation and Recipient T Regs Therapy in Living Donor Kidney Transplantation

Recruiting now · Phase 1

Conditions studied: Living Donor Kidney Transplantation

In brief

This study will determine whether a preparatory regimen including total lymphoid irradiation (TLI), total body irradiation (TBI), anti-thymocyte globulin (ATG) and infusion of the donor hematopoietic stem cells when given along with recipient regulatory T cells (Tregs) will allow for eventual discontinuation of anti-rejection drugs after living donor kidney transplantation.

Key facts

Study ID

NCT03943238

Run by

Stanford University

People needed

22

Starts

2020-02-01

Expected to finish

2029-12-01

Last updated by the study team

2026-07-01

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All consenting adults who are 18 to 65 years, living donor renal transplant recipients at Stanford University Medical Center or Northwestern Medicine who have a haplotype matched (minimum single Human Leukocyte Antigen - DR locus (HLA-DR) and HLA-A or B match) living related or unrelated donor.
• Patients who agree to participate in the study and sign an Informed Consent.
• Patients who have no known contraindication to administration of rabbit ATG or radiation.
• Males and females of reproductive potential who agree to practice a reliable form of contraception for at least 1 year posttransplant

You may not qualify if…

• Previous treatment with rabbit ATG or a known allergy to rabbit proteins.
• History of malignancy with the exception of non-melanoma skin malignancies.
• Pregnant women or nursing mothers.
• Serological evidence of HIV, Hepatitis B surface antigen positive (HBsAg+), or Hepatitis C infection. Epstein Barr Virus (EBV) positive to EBV negative.
• Leukopenia (with a white blood cell count < 3000/mm3) or thrombocytopenia (with a platelet count < 100,000/mm3).
• Panel Reactive Antibody (PRA) greater than 80% or demonstration of historic and/or current donor specific antibody (DSA)
• Prior organ transplantation
• High risk of primary kidney disease recurrence
• Advanced coronary or vascular disease.

Where it is running

• Stanford University — Palo Alto, California, United States (enrolling)
• Nothwestern University — Chicago, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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