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The purpose of this study is to determine whether treatment with rituximab in people who develop new anti-HLA antibodies after kidney transplant will promote longer-term survival of the transplanted kidney.
Organ rejection occurs when a patient's body does not recognize the new organ and attacks it. Data suggest that the development of anti-human leukocyte antigen (HLA) antibodies is an early clinical indication that organ rejection may occur. Rituximab is a genetically engineered monoclonal antibody directed against the CD20 antigen on B cells and is known to deplete B cells when administered intravenously; it is FDA-approved for the treatment of non-Hodgkin's lymphoma. In a previous small study, kidney transplant patients with either acute humoral rejection (AHR) or chronic humoral rejection (CHR) were given rituximab and other antilymphocyte therapy. Patients with AHR had lower or undetectable levels of circulating anti-HLA antibodies after study treatment, and patients with CHR had a sustained decrease of anti-HLA antibodies to undetectable after 6 to 9 months. This new study will evaluate the safety and efficacy of rituximab in preventing organ rejection and promoting long-term survival of donor kidneys in people who undergo kidney transplantation.
The study will last 8 years. The study will enroll participants for 3 years, and patients will participate in the study for 2 to 5 years. This study involves two stages.
Stage 1 begins 3 to 36 months after transplant. During Stage 1, blood collection will occur every 3 months for up to 36 months after transplant to test for anti-HLA antibodies. When these antibodies are detected twice within 1 month, the patient will undergo a baseline kidney biopsy and have his or her glomerular filtration rate (GFR) measured to determine kidney function. If a patient meets certain study criteria, he or she will enter Step 2.
If anti-HLA antibodies are not detected in a patient's blood during Stage 1, the patient's participation will be complete.
In Stage 2, patients will be randomly assigned to one of two study treatment groups:
- Group 1 adult participants, 18 years of age or older, will receive an intravenous infusion of 1000mg of rituximab at Days 0 and 14. Group 1 pediatric participants, 18 years of age or younger, will receive an intravenous infusion of 375 mg/m2 of rituximab at Days 0, 8, 15 and 22.
- Group 2 adult participants, 18 years of age or older, will receive an intravenous infusion of 1000mg of placebo at Days 0 and 14. Group 2 pediatric participants, 18 years of age or younger, will receive an intravenous infusion of 375 mg/m2 of placebo at Days 0, 8, 15, and 22.
All participants will also receive standard of care immunosuppressive drugs. Adult participants, 18 years of age or older, will have 9 study visits over 24 months. Pediatric participants, 18 years of age or younger, will have 11 study visits over 24 months. A physical exam, medication history, adverse events assessment, and blood and urine collection will occur at all visits. A biopsy of the kidney transplant will occur at Stage 2 entry and Month 24.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Rituximab, Immunosuppressive drugs
University of Alabama, Pediatric Nephrology
National Institute of Allergy and Infectious Diseases (NIAID)
Published on BioPortfolio: 2014-08-26T22:45:30-0400
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Preparative treatment of transplant recipient with various conditioning regimens including radiation, immune sera, chemotherapy, and/or immunosuppressive agents, prior to transplantation. Transplantation conditioning is very common before bone marrow transplantation.
Deliberate prevention or diminution of the host's immune response. It may be nonspecific as in the administration of immunosuppressive agents (drugs or radiation) or by lymphocyte depletion or may be specific as in desensitization or the simultaneous administration of antigen and immunosuppressive drugs.
The end-stage of CHRONIC RENAL INSUFFICIENCY. It is characterized by the severe irreversible kidney damage (as measured by the level of PROTEINURIA) and the reduction in GLOMERULAR FILTRATION RATE to less than 15 ml per min (Kidney Foundation: Kidney Disease Outcome Quality Initiative, 2002). These patients generally require HEMODIALYSIS or KIDNEY TRANSPLANTATION.
The transference of a kidney from one human or animal to another.
Anti-CD3 monoclonal antibody that exerts immunosuppressive effects by inducing peripheral T-cell depletion and modulation of the T-cell receptor complex (CD3/Ti). This biochemically purified IMMUNOGLOBULIN G is obtained through the fusion of mouse myeloma cells to lymphocytes from immunized animals to produce hybridomas that secrete specific antibodies to the T3 (CD3) antigens of human T-lymphocytes. It is often used as an IMMUNOSUPPRESSIVE AGENTS in TRANSPLANTATION.