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New treatment option for Immune Tolerance
Official title Delayed Blood Stem Transplantation in HLA Matched Kidney Transplant Recipients to Eliminate Immunosuppressive Drugs.
ClinicalTrials.gov ID: NCT03591302
What this study is testing
What is Hematopoietic cell transplantation?
Hematopoietic cell transplantation is an investigational medicine, given as a twice-daily infusion into a vein, being studied as a potential treatment for immune tolerance.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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Globulin (rATG) and an HLA matched donor hematopoietic progenitor cell infusion such that their drugs are successfully withdrawn while maintaining normal renal function.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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...
- 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
You likely can't join 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.
See the full eligibility criteria
- 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.