A Prospective Open-Labeled Randomized Study of Rituximab Versus Standard of Care, for Treatment of Acute Allograft Rejection in Pediatric Renal Transplantation
Rituximab will be tested for its safety and potential efficacy in treating B cell dense renal allograft rejection episodes in children receiving renal transplants at Stanford University
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : Rituximab for transplant rejection
Phase: Phase 2/Phase 3
Ages Eligible For Study:
Patients must meet the following inclusion criteria to be eligible for study entry: - Pediatric renal allograft recipients aged 2-21 years with biopsy proven acute rejection episodes. - Able and willing to give written informed consent and comply with the requirements of the study protocol (patients >18 years of age or parents) - Greater than 30% decline in baseline renal function as indicated by a rise in the serum creatinine. - Adequate liver function, as indicated by AST or ALT <2x upper limit of normal unless related to primary disease. - Negative serum pregnancy test (for women of child bearing age) - Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for twelve months (1 year) after completion of treatment.