Actively Recruiting
Delayed Immunological Tolerance in Patients With Well-functioning Pre-existing HLA-matched Kidney Transplants
Led by University of California, Los Angeles · Updated on 2025-11-26
10
Participants Needed
1
Research Sites
205 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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determine if patients with a pre-existing, well-functioning kidney transplant from a HLA-identical living donor can be withdrawn from immunosuppressive medications without compromising allograft function through hematopoietic stem cell (HPSC) infusion from the same donor.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).
CONDITIONS
Official 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 time of planned stem cell infusion
- No history of rejection with current kidney transplant
- No major complications after transplant such as new cancer, active infection, or rejection
- Stable kidney function as determined by investigator
- Ability to give informed consent and agree to participate in the study
- Meet institutional criteria for hematopoietic stem cell infusion
- Willing to stay within 3 hours of UCLA Medical Center for first 3 to 6 months
- No known contraindications to rabbit anti-thymocyte globulin or radiation
- Women of childbearing potential must have negative pregnancy test and agree to use contraception for 12 months post-transplant
- Karnofsky Performance Score of 70 or higher
- Adequate heart function with left ventricular ejection fraction 40% or higher
- Adequate liver function within specified lab limits
- Adequate social support as evaluated by transplant team
You will not qualify if you...
- Donor is an identical twin
- Major blood type incompatibility between donor and recipient
- Positive donor-specific HLA antibody
- History of multiple organ transplants
- History of rejection with current kidney transplant
- Allergy to rabbit proteins
- Major post-transplant complications including active infection, rejection, or new malignancy except low-risk cancers with good prognosis
- Active or recent malignancy within 5 years except certain low-risk or treated cancers
- Worsening kidney function in last 3 months
- Pregnant or breastfeeding
- Low white blood cell or platelet counts
- Active infections including hepatitis B, C, or other serious infections
- Positive HIV or HTLV tests
- Kidney disease with high risk of recurrence
- Advanced liver fibrosis or cirrhosis due to hepatitis
- Uncontrolled illnesses like heart failure or autoimmune diseases needing immunosuppression
- Neuropsychiatric conditions affecting consent or compliance
- Recent use of immunomodulatory or immunotherapy drugs within 6 months
- Current or recent substance abuse
- Body mass index 40 or higher
- Donor exclusion criteria including pregnancy, infections, malignancy history, or inability to tolerate donation procedures
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
UCLA
Los Angeles, California, United States, 90095
Actively Recruiting
Research Team
R
Ruth Wynne Jones
CONTACT
J
Jenny Lester, MPH
CONTACT
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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