NCT03943238 TLI, TBI, ATG & Hematopoietic Stem Cell Transplantation and Recipient T Regs Therapy in Living Donor Kidney Transplantation
| NCT ID | NCT03943238 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Stanford University |
| Condition | Living Donor Kidney Transplantation |
| Study Type | INTERVENTIONAL |
| Enrollment | 22 participants |
| Start Date | 2020-02-01 |
| Primary Completion | 2029-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 22 participants in total. It began in 2020-02-01 with a primary completion date of 2029-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will determine whether a preparatory regimen including total lymphoid irradiation (TLI), total body irradiation (TBI), anti-thymocyte globulin (ATG) and infusion of the donor hematopoietic stem cells when given along with recipient regulatory T cells (Tregs) will allow for eventual discontinuation of anti-rejection drugs after living donor kidney transplantation.
Eligibility Criteria
Inclusion Criteria: 1. All consenting adults who are 18 to 65 years, living donor renal transplant recipients at Stanford University Medical Center or Northwestern Medicine who have a haplotype matched (minimum single Human Leukocyte Antigen - DR locus (HLA-DR) and HLA-A or B match) living related or unrelated donor. 2. Patients who agree to participate in the study and sign an Informed Consent. 3. Patients who have no known contraindication to administration of rabbit ATG or radiation. 4. Males and females of reproductive potential who agree to practice a reliable form of contraception for at least 1 year posttransplant Exclusion Criteria: 1. Previous treatment with rabbit 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 surface antigen positive (HBsAg+), or Hepatitis C infection. Epstein Barr Virus (EBV) positive to EBV negative. 5. Leukopenia (with a white blood cell count \< 3000/mm3) or thrombocytopenia (with a platelet count \< 100,000/mm3). 6. Panel Reactive Antibody (PRA) greater than 80% or demonstration of historic and/or current donor specific antibody (DSA) 7. Prior organ transplantation 8. High risk of primary kidney disease recurrence 9. Advanced coronary or vascular disease.
Contact & Investigator
Everett Meyer, MD
STUDY DIRECTOR
Stanford University
Frequently Asked Questions
Who can join the NCT03943238 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Living Donor Kidney Transplantation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03943238 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03943238 currently recruiting?
Yes, NCT03943238 is actively recruiting participants. Contact the research team at kevinly@stanford.edu for enrollment information.
Where is the NCT03943238 trial being conducted?
This trial is being conducted at Palo Alto, United States, Chicago, United States.
Who is sponsoring the NCT03943238 clinical trial?
NCT03943238 is sponsored by Stanford University. The principal investigator is Everett Meyer, MD at Stanford University. The trial plans to enroll 22 participants.
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