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

Launched by STEPHAN BUSQUE · Jul 9, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to help kidney transplant recipients stop taking immunosuppressive drugs safely. Immunosuppressive drugs are necessary to prevent the body from rejecting the transplanted kidney, but they can have side effects. The trial will involve patients who have had a kidney transplant from a compatible donor (like a sibling) for at least one year and wish to discontinue these medications. The treatment being tested includes a special kind of radiation and a type of medication that helps to prepare the body for receiving stem cells from the donor. The goal is to see if this treatment can allow patients to stop taking their immunosuppressive drugs while keeping their kidney function normal.

To be eligible for the trial, participants must be at least 18 years old, have a kidney transplant from a matched sibling donor, and have had no rejection episodes. They also need to have a willing donor who meets certain health criteria. The study is open to both men and women, but they must agree to use birth control for 18 months after the transplant. Participants can expect close monitoring throughout the study to ensure their safety and to check how well their kidneys are functioning without the drugs. Overall, this trial could offer a new hope for kidney transplant recipients looking to improve their quality of life.

Gender

ALL

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.