RecruitingPhase 1NCT05525507

Delayed Immunological Tolerance in Patients With Well-functioning Pre-existing HLA-matched Kidney Transplants

A Single-armed, Unblinded, Non-randomized Feasibility Study of Hematopoietic Stem Cell Infusion Following a Conditioning Regimen of Total Lymphoid Irradiation (TLI) and Anti-thymocyte Globulin (ATG) in Patients With a Pre-existing, Well-functioning HLA-matched Kidney Transplant

Sponsor

University of California, Los Angeles

Enrollment

10 participants

Start Date

Dec 21, 2022

Study Type

INTERVENTIONAL

Conditions

Chronic Kidney Diseases End-stage Kidney Disease Kidney Transplant Failure and Rejection Immunological Tolerance

Summary

The study seeks to determine if patients with a pre-existing, well-functioning kidney transplant from a HLA-identical living donor can be withdrawn from immunosuppressive medications without compromising allograft function through hematopoietic stem cell (HPSC) infusion from the same donor. HPSC infusion will be preceded by a conditioning regimen of total lymphoid irradiation (TLI) and rabbit anti-thymocyte globulin (rATG).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is exploring whether kidney transplant recipients can eventually stop taking anti-rejection medications by receiving an infusion of blood stem cells from their original living kidney donor. The goal is to train the immune system to accept the transplanted kidney as its own — a state called tolerance. **You may be eligible if...** - You are 18 or older and received a kidney from a living, HLA-matched (closely matched) donor - Your transplant was between 3 months and 5 years ago - Your kidney is working well and you have had no rejection episodes - You are free of serious complications like active infection, new cancers, or rejection - You are able to live within 3 hours of UCLA Medical Center for the first 3–6 months - You have a heart ejection fraction of at least 40% **You may NOT be eligible if...** - You have a contraindication to the conditioning medications (anti-thymocyte globulin or low-dose radiation) - You are pregnant or unwilling to use contraception - Your Karnofsky Performance Score is below 70 (significant limitation in daily activities) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTConditioning and Stem cell infusion

Patients will undergo a conditioning with TLI and ATG, followed by infusion of hematopoietic stem cells from the same HLA-identical donor that provided the original kidney