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

Total Lymphoid Irradiation, Anti-Thymocyte Globulin and Purified Donor CD34+ and T-cell Transfusion to Withdraw Immunosuppressive Drugs From Recipients of a Previous HLA Matched Living Donor Kidney Transplantation .

This study is testing whether kidney transplant patients can safely stop taking their immunosuppressive drugs by using a special treatment with blood stem cells.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Stanford University (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Palo Alto, California)
• Trial ID: NCT03591302 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with functioning HLA matched living donor kidney transplants who have no history of acute or chronic rejection.

Not a fit: Patients with known allergies to rabbit proteins or a history of malignancy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could allow kidney transplant recipients to live without the need for lifelong immunosuppressive drugs.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in achieving immune tolerance in transplant recipients.

Eligibility criteria

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 this trial is running

Palo Alto, California

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

Study contacts

• Study coordinator: Stephan Busque, Md

Conditions Immune Tolerance; Kidney Transplantation; Blood Stem Cell Transplantation