Rituximab in Renal Allograft Recipients Who Develop Early De Novo Anti-HLA Alloantibodies

Conditions: Kidney Transplant, Kidney Transplant Recipient, Graft Function/Survival, de Novo HLA Antibodies Development

Sex: All

Ages: 5 Years – 70 Years

Healthy volunteers: No

Phase: PHASE2

Enrollment: 757

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Summary

The purpose of this study is to determine whether treatment with rituximab (anti-CD20, Rituxan®, MabThera®) in individuals who develop new anti-HLA antibodies after renal (kidney) transplant will promote longer-term survival of the transplanted kidney.The pilot study compares the use of rituximab (Rituxan®) + site-specific standard immunosuppression to placebo + site-specific standard immunosuppression in the treatment of circulating anti-HLA antibodies in subjects who develop de novo anti-HLA antibodies between 3-36 months after transplant.

Eligibility Criteria

Stage 1 Inclusion Criteria for All Participants: * Willing to provide informed consent * Previously diagnosed end stage renal disease (ESRD) * Received kidney transplant within 3 and 36 months of study entry * Willing to comply with the study protocol * Willing to use acceptable forms of contraception during the study and for 12 months following rituximab/placebo therapy * Willing to refrain from breastfeeding during the study and for 12 months following rituximab therapy Stage 1 Inclusion Criteria for Pediatric Participants (\

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT00307125). StuddyBuddy aggregates publicly available trial information.