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

Completed · Phase 2 · Has a placebo group

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

In brief

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.

Key facts

Study ID
NCT00307125
Run by
National Institute of Allergy and Infectious Diseases (NIAID)
People needed
757
Starts
2006-03-01
Expected to finish
2012-12-01
Last updated by the study team
2015-03-23

Who can join

Age: 5 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

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