Actively Recruiting
Hematopoietic Stem Cell Infusion After Conditioning With Total Lymphoid Irradiation and Anti-thymocyte Globulin in Patients With Pre-existing HLA-matched Kidney Transplants to Assess Immunological Tolerance
Led by University of California, Los Angeles · Updated on 2025-11-26
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying whether patients with a well-functioning kidney transplant from an HLA-identical living donor can stop taking immunosuppressive medications safely by receiving an infusion of hematopoietic stem cells (HPSC) from the same donor. This study explores a process called retroactive tolerance induction, using a conditioning treatment of total lymphoid irradiation (TLI) and anti-thymocyte globulin (ATG) before the stem cell infusion. The goal is to avoid lifelong immunosuppression without harming the kidney transplant function. Participants will first undergo a conditioning regimen involving TLI and rabbit anti-thymocyte globulin (rATG). Following this, they will receive an infusion of hematopoietic stem cells from their original HLA-identical kidney donor. After the infusion, researchers will monitor the patients to see if they can safely reduce and eventually stop immunosuppressive drugs like tacrolimus, starting at 6 months and aiming for full discontinuation by 12 months if certain conditions are met, including evidence of donor cell presence, stable kidney function, and no signs of graft versus host disease. Throughout the study, patients will have regular assessments to monitor kidney graft function and blood tests to measure chimerism, or the presence of donor cells, in different blood cell types. The main outcome measured is whether patients can successfully stop immunosuppression by 12 months. Secondary outcomes include monitoring for rejection and graft survival up to 48 and 24 months respectively. Participants will be followed closely for safety and kidney health during the trial period.
CONDITIONS
Brief Title
Delayed Immunological Tolerance in Patients With Well-functioning Pre-existing HLA-matched Kidney Transplants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older with a pre-existing kidney transplant from an HLA-matched living donor
- Kidney transplant must be between 3 months and 5 years old at the time of scheduled stem cell infusion
- No history of rejection with current HLA-matched kidney transplant
- No major post-transplant complications such as active infection or malignancy
- Stable kidney function as determined by the investigator
- Ability to provide informed consent and agree to participate
- Meets institutional criteria for hematopoietic stem cell infusion
- Willing to stay within 3 hours of UCLA Medical Center for the first 3 to 6 months of the study
- No known contraindications to anti-thymocyte globulin or radiation
- Females of reproductive potential must have a negative pregnancy test and agree to reliable contraception for 12 months post-transplant
- Karnofsky Performance Score of 70 or greater
- Adequate cardiac function with left ventricular ejection fraction of 40% or higher
- Adequate liver function within specified limits
- Adequate social support as evaluated by the transplant team
You will not qualify if you...
- Recipient is an identical twin
- Major ABO blood type incompatibility with donor
- Positive donor-specific HLA antibody
- History of multi-organ transplantation
- History of rejection with current HLA-matched kidney transplant
- Allergy to rabbit proteins
- Post-transplant major complications like active or chronic infection or malignancy (except low-risk early-stage cancers with good prognosis)
- Active malignancy within 5 years except certain low-risk or treated cancers without active disease
- Worsening kidney function over past 3 months
- Pregnant or breastfeeding
- Low white blood cell or platelet counts
- Active infections including hepatitis B or C
- Positive for HIV or HTLV infections
- Kidney diseases with high recurrence risk
- Advanced liver fibrosis or cirrhosis from hepatitis
- Uncontrolled illnesses such as heart failure or arrhythmia
- Active autoimmune diseases requiring immunosuppression
- Neuropsychiatric conditions interfering with consent or compliance
- Recent use of certain immunomodulatory or immunotherapy drugs within 6 months
- Current alcohol or drug abuse
- Body mass index 40 or higher
- Donor-specific exclusions including pregnancy, infections, malignancies, or inability to tolerate donation procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants undergo screening to confirm eligibility based on health status and transplant history.
Duration - Duration of conditioning and infusion period as per protocol
Participants undergo a conditioning regimen with total lymphoid irradiation (TLI) and anti-thymocyte globulin (ATG), followed by infusion of hematopoietic stem cells from the original HLA-identical kidney donor.
Multiple visits for conditioning treatments and stem cell infusion
Duration - Up to 12 months
Participants are monitored while receiving immunosuppressive therapy, with plans to wean tacrolimus starting at 6 months and aiming for discontinuation within 12 months if certain criteria are met.
Regular monitoring visits during immunosuppressive drug weaning
Duration - Up to 48 months
Participants are followed to monitor graft function, chimerism, and to detect any rejection or graft-versus-host disease after immunosuppressive drug discontinuation.
Periodic follow-up visits for long-term monitoring
Trial Site Locations
Total: 1 location
1
UCLA
Los Angeles, California, United States, 90095
Actively Recruiting
Research Team
R
Ruth Wynne Jones
J
Jenny Lester, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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