Delayed Blood Stem Transplantation in HLA Matched Kidney Transplant Recipients to Eliminate Immunosuppressive Drugs.

Recruiting now · Phase 1

Conditions studied: Immune Tolerance

In brief

The study will determine whether patients with functioning Human Leukocyte Antigen (HLA) matched kidney transplants for at least one year and who want to discontinue immunosuppressive drugs can be treated with Total Lymphoid Irradiation (TLI) and rabbit Anti-Thymocyte Globulin (rATG) and an HLA matched donor hematopoietic progenitor cell infusion such that their drugs are successfully withdrawn while maintaining normal renal function.

Key facts

Study ID

NCT03591302

Run by

Stephan Busque

People needed

25

Starts

2024-02-02

Expected to finish

2028-10-01

Last updated by the study team

2026-07-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All consenting adults of age 18 years and older with previous HLA matched sibling living donor renal transplants who still have their HLA- matched kidney donor available, and who have no history of acute or chronic rejection.
• Patients who agree to participate in the study and sign an Informed Consent
• The HLA-matched donor meets the Stanford Bone Marrow Transplant criteria for stem cell donation, agrees to participate and has signed an Informed Consent.
• The pair is confirmed to be HLA-matched (2 haplo type match) as determined by the histocompatibility laboratory at Stanford.
• Patients who have no known contraindication to the administration of rabbit ATG or radiation
• Males and females of reproductive potential who agree to practice a reliable form of contraception for at least 18 months post transplant.

You may not qualify if…

• Known allergy to 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 (HepBsAg+) or Hepatitis C infection.
• Leukopenia (with a white blood cell count < 3000/mm3) or thrombocytopenia (platelet count < 100,000/mm3)
• Previous history of acute or chronic rejection of the kidney transplant or recurrence of the original disease.
• Screening kidney biopsy demonstrating acute or chronic rejection, recurrence of original disease or interstitial fibrosis/Tubular Atrophy (IF/TA) score greater than 1.

Where it is running

• Stanford University Medical Center — Palo Alto, California, United States (enrolling)

Full record on ClinicalTrials.gov

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