Pilot Trial to Assess Effect of CNI Conversion of Efalizumab on T Reg Cells
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|ClinicalTrials.gov Identifier: NCT00777400|
Recruitment Status : Withdrawn (New safety information reported in the post-marketing setting with efalizumab for treatment of chronic plaque psoriasis and trial conduct feasibility issues.)
First Posted : October 22, 2008
Last Update Posted : May 14, 2013
|Condition or disease||Intervention/treatment||Phase|
|Autoimmune Diseases||Drug: Efalizumab||Phase 1 Phase 2|
The objective of this pilot trial is to determine whether the conversion from calcineurin inhibitors (CNI) and mycophenolate mofetil (MMF) to efalizumab and sirolimus is associated with an increase in T regulatory cells and does not result in an increase in acute rejection following conversion. CNIs are associated with progressive nephrotoxicity, increased cardiovascular risk factor as well as an inhibitory effect on T regulatory cells.
To determine if the combination of efalizumab and sirolimus results in a significant increase in T regulatory cells. A hundred percent increase in T regulatory cells will be determined to be an important biologic effect of the combination of efalizumab and sirolimus.
To assess the feasibility of the conversion from CNI/MMF to efalizumab/sirolimus and to determine that this combination is safe and effective
To determine if there is an increase in FoxP3 mRNA in the urine of converted patients. Urine FoxP3 is believed to correlate with T regs in the kidney.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Trial to Assess the Effect of CNI Conversion to Efalizumab in T Regulatory Cells in Renal Transplantation|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||April 2009|
|Actual Study Completion Date :||April 2009|
Efalizumab will be started on Day 0 until the end of the study at Week 24. At the end of the first week, after efalizumab is started, cyclosporine or tacrolimus will be decreased by 50% and at 2 weeks the dose of cyclosporine or tacrolimus will be completely discontinued. At 12 weeks Cellcept or myfortic will be discontinued and the patient will be converted to sirolimus for the remainder of the study.
1 mg/kg of efalizumab administered sub q once weekly
- To determine if the combination of efalizumab and sirolimus results in a significant increase in T regulatory cells. [ Time Frame: Month 6 ]
- The successful conversion from CNI to non-CNI regimen without increasing the rejection rate by more than 20%. [ Time Frame: 6 Months ]
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): NCT00777400
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94143|
|Principal Investigator:||Flavio Vincenti, M.D.||University of California, San Francisco|