Rituximab Treatment to Block HLA Antibodies in Renal Transplant Recipients
- Sponsor
- Massachusetts General Hospital
- Study ID
- NCT00261547
- Phase
- PHASE1/PHASE2
- Status
- Withdrawn
Conditions
- Chronic Rejection
- Kidney Insufficiency
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 64 Years
- Healthy Volunteers
- Not accepted
Interventions
- Rituximab — DRUGAll subjects will be treated with Rituximab 1000 mg (1 g) intravenously on days 1 and 15.
Study Details
The purpose of this study is to determine if administration of rituximab blocks the development of donor specific antibodies (DSA) in transplant recipients who have developed renal dysfunction and DSA after renal transplant. It is hoped that by blocking DSA production renal function will stabilize or improve.
Key Dates
- Start date
- Dec 31, 2005
- Status verified
- Oct 2023
- Primary completion
- Nov 30, 2007
- Completion
- Nov 30, 2007
Study Design
- Enrollment
- 0 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Rituximabthis study has only one arm as the treatment group
Primary Outcome Measure
Negative DSA by Luminex beads or ELISA [ Time Frame: at 12 months post study medication ]