Actively Recruiting
Study of Combined Kidney and Blood Stem Cell Transplant From a Brother or Sister Donor
Led by Jeffrey Veale, MD · Updated on 2026-05-08
15
Participants Needed
1
Research Sites
390 weeks
Total Duration
On this page
Sponsors
J
Jeffrey Veale, MD
Lead Sponsor
O
OneLegacy Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to find out if an investigational treatment will allow kidney transplant recipients to better accept their new kidney and stop immunosuppressive medicines. This study is for kidney transplant recipients who receive a kidney from a sibling donor. The investigational treatment is started after kidney transplant. It begins with a regimen of a drug called rabbit anti-thymocyte globulin (rATG) combined with radiation therapy (known as total lymphoid irradiation, or TLI) to the lymph nodes and spleen. This is followed by an infusion of blood stem cells, which will be donated by the same sibling who donated their kidney. Researchers think that this treatment allows immune cells from the donor and recipient to live side by side, a condition referred to as "mixed chimerism." Mixed chimerism may help create a state of "tolerance" in kidney transplant recipients in which all immunosuppressive medications can be stopped without rejection of the transplanted kidney. This study will test whether (1) the investigational treatment will allow patients to stop immunosuppressive medications after their kidney transplant and (2) if the treatment impacts the rate of kidney rejection and the side effects of immunosuppressive medications.
CONDITIONS
Official Title
Study of Combined Kidney and Blood Stem Cell Transplant From a Brother or Sister Donor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older receiving a kidney transplant from an HLA-identical sibling at UCLA Medical Center
- Able and willing to provide informed consent
- Lives or can stay within 3 hours of UCLA Medical Center for the first 3 to 6 months of the trial
- Meets institutional criteria for kidney and hematopoietic stem cell transplant
- No known contraindications to rabbit anti-thymocyte globulin or radiation
- Female participants of reproductive potential must have a negative pregnancy test and agree to use reliable contraception for at least 12 months post-transplant
- Karnofsky Performance Score of 70 or higher
- Adequate heart function with left ventricular ejection fraction of 40% or higher
- Adequate lung function with FVC and DLCO at or above 50% of predicted values
- Adequate liver function with total bilirubin at or below 1.5 times normal and AST/ALT at or below 2 times normal
- Adequate social support as evaluated by the UCLA renal transplant team social worker
You will not qualify if you...
- Donor is an identical twin
- ABO blood type incompatibility with donor
- Previous solid organ transplant
- Multi-organ transplantation
- Previous treatment with rabbit anti-thymocyte globulin or allergy to rabbit proteins
- History of active cancer within the past 5 years, except certain low-risk or treated cancers
- Pregnant or lactating
- Low white blood cell count (below 3,000/µL) or low platelet count (below 100,000/µL)
- Active bacterial, fungal, mycobacterial, or viral infection including active hepatitis B or C
- Positive for HLA donor-specific antibodies
- Seropositive for HIV 1 or 2, HTLV I or II
- Active West Nile virus infection
- Kidney disease with high risk of recurrence such as focal segmental glomerulosclerosis
- Advanced liver fibrosis or cirrhosis due to hepatitis B or C
- Uncontrolled illnesses including congestive heart failure, unstable angina, or arrhythmias
- Active autoimmune diseases requiring immunosuppression
- Neuropsychiatric illness preventing informed consent or compliance
- Use of certain immunosuppressive or immunotherapy drugs within 6 months before the study
- Current or recent alcohol or drug abuse within 6 months
- Body mass index of 40 or greater
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of California, Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
Research Team
R
Ruth Wynne Jones
CONTACT
J
Jenny Lester
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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