Eliminating immunosuppressive drugs in kidney transplant recipients using blood stem cell transplantation.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of Total Lymphoid Irradiation (TLI) and rabbit Anti-Thymocyte Globulin (rATG) combined with HLA matched donor hematopoietic progenitor cell infusion in kidney transplant recipients. The participants will be adults with functioning HLA matched kidney transplants for at least one year who wish to discontinue their immunosuppressive medications. The study will monitor graft function, chimerism in white blood cell subsets, and conduct protocol biopsies to assess the success of drug withdrawal while maintaining normal kidney function. A total of 25 patients will be enrolled in this single-center, open-label study at Stanford University Medical Center.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 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.
2. Patients who agree to participate in the study and sign an Informed Consent
3. The HLA-matched donor meets the Stanford Bone Marrow Transplant criteria for stem cell donation, agrees to participate and has signed an Informed Consent.
4. The pair is confirmed to be HLA-matched (2 haplo type match) as determined by the histocompatibility laboratory at Stanford.
5. Patients who have no known contraindication to the administration of rabbit ATG or radiation
6. Males and females of reproductive potential who agree to practice a reliable form of contraception for at least 18 months post transplant.

Exclusion Criteria:

1. Known allergy to ATG or a known allergy to rabbit proteins.
2. History of malignancy with the exception of non-melanoma skin malignancies.
3. Pregnant women or nursing mothers.
4. Serological evidence of HIV, Hepatitis B (HepBsAg+) or Hepatitis C infection.
5. Leukopenia (with a white blood cell count \< 3000/mm3) or thrombocytopenia (platelet count \< 100,000/mm3)
6. Previous history of acute or chronic rejection of the kidney transplant or recurrence of the original disease.
7. 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's running

• Stanford University Medical Center
  Palo Alto, California, United States Recruiting

Study contacts

• Principal investigator: Stephan Stephan, MD, MS — Stanford University
• Study coordinator: Stephan Stephan, MD, MS
• Email: sbusque@stanford.edu
• Phone: 6504986189

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.