Rituximab for Pediatric Renal Transplant Rejection

Kidney Transplantation Clinical Trial

Official title: A Prospective Open-Labeled Randomized Study of Rituximab Versus Standard of Care, for Treatment of Acute Allograft Rejection in Pediatric Renal Transplantation

Status Completed

Clinical Trial Summary

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

Clinical Trial Description

Twenty kidney transplant recipients who are being cared for at Stanford University and UCLA and are between the ages of 2-21, can be considered for participation in this research if they are having an acute rejection episode. After a biopsy is done and the diagnosis of acute rejection is made, ten patients will be randomly enrolled in the group to be treated with Rituximab and steroid pulses. Ten children will be enrolled as the control group, receiving standard of care for acute transplant rejection.

Assignment will be based on a 1:1 randomization scheme. That means two patients will be assigned to the group of patients receiving steroid pulsing and 4 doses of Rituximab. The third patient would be assigned to the group receiving steroid pulses and adjustment in immunosuppression medications which is the standard of care at Stanford University.

The dose of Rituximab that will be given is 375 mg/m2 and is administered through an IV. Additional doses of Rituximab will be administered on a weekly basis. A total of four doses will be given.

If the acute rejection does not resolve by one-week, patients in both groups have the option of receiving polyclonal antibody therapy. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Transplantation

• NCT number: NCT00697996
• Study type: Interventional
• Source: Stanford University
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: June 2005
• Completion date: August 2007