Rituximab Treatment to Block HLA Antibodies in Renal Transplant Recipients
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|ClinicalTrials.gov Identifier: NCT00261547|
Recruitment Status : Completed
First Posted : December 5, 2005
Last Update Posted : February 25, 2008
|Condition or disease||Intervention/treatment||Phase|
|Chronic Rejection Kidney Insufficiency||Drug: Rituximab||Phase 1 Phase 2|
A long established risk factor for late renal allograft loss is the development of DSA. Recent studies from our group and others have shown that these antibodies are probably responsible for chronic rejection by attacking the vascular endothelium and fixing complement (detected as C4d in renal biopsies). Studies in humans and monkeys have shown that circulating antibody and complement deposition precede the development of chronic graft injury. Interruption of antibody production is a potential beneficial strategy to prevent late graft loss from this mechanism.
Therapeutic regimens that have been used in an attempt to deplete HLA or ABO antibodies include plasmapheresis, IVIg, tacrolimus and mycophenolate mofetil (MMF), and anti-CD20 (rituximab). Of these regimens, the most specific is anti-CD20, rituximab (rituxan), a therapy now FDA approved for B cell proliferative diseases. Although initially introduced for the treatment of neoplasm, the humoral immunosuppressant effects of rituximab have been shown to have clinical significance. Rituximab interferes with both primary and secondary humoral responses by eliminating B-cells prior to antigen exposure, thus interfering with differentiation into antibody secreting cells and specific antibody production.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Rituximab Treatment to Inhibit HLA Antibodies in Renal Allograft Recipients|
|Study Start Date :||December 2005|
|Actual Primary Completion Date :||November 2007|
|Actual Study Completion Date :||November 2007|
this study has only one arm as the treatment group
All subjects will be treated with Rituximab 1000 mg (1 g) intravenously on days 1 and 15.
Other Name: Rituxan
- Negative DSA by Luminex beads or ELISA [ Time Frame: at 12 months post study medication ]
- Lack of C4d deposition in peritubular capillary [ Time Frame: on 12 month renal biopsy ]
- Renal allograft function: Serum creatinine, Calculated creatinine clearance, Urine protein, Urine protein-creatinine ratio [ Time Frame: 12 months after study entry compared to the baseline ]
- Change in chronic rejection pathology indices [ Time Frame: on 12-month renal biopsy compared to baseline biopsy. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00261547
|Principal Investigator:||Nina Tolkoff-Rubin, M.D.||Massachusetts General Hospital|