Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

San Francisco, California 94143


Purpose:

The purpose of this pilot trial is to determine whether a conversion from calcineurin inhibitors (CNI) and mycophenolate mofetil (MMF) to a regimen consisting of efalizumab and sirolimus is associated with an increase in T regulatory cells, white cells that control the immune system and can prevent autoimmune diseases like arthritis or rejection of foreign organs,and does not result in an increase in acute rejection.


Study summary:

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. PRIMARY OBJECTIVE: 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. SECONDARY OBJECTIVES: 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.


Criteria:

Inclusion Criteria: - Ability to provide written informed consent and comply with study assessments for the full duration of the study. - Male or female, 18-70 years - Recipients of primary renal transplants from living and deceased donors - Stable renal function for 4 weeks prior to entry into the study - No history of acute rejection - Pretransplant negative crossmatch - Hematocrit >30% at the time of inclusion, platelet count >100,000 and WBC ≥ 3.0 - If a female of childbearing potential, a negative pregnancy test and commitment to the use of two forms of effective contraception (birth control) for the duration of the study are necessary. - If a non-sterile male, commitment to the use of two forms of effective contraception (birth control) for the duration of the study is necessary. Exclusion Criteria: - Patients with known hypersensitivity to Raptiva® (efalizumab) or any of its components. - Pregnant or lactating women - Pretransplant PRA >20% - cGFR < 35/ml/min - >500 mg protein as estimated by spot protein/creatinine ratio - Recipients of other organ transplants - Subject has a current malignancy or a history of malignancy, except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully. - Patients receiving experimental immunosuppressive agents - Prior enrollment in the study - Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated. - Participation in another simultaneous medical investigation or trial


NCT ID:

NCT00777400


Primary Contact:

Principal Investigator
Flavio Vincenti, M.D.
University of California, San Francisco


Backup Contact:

N/A


Location Contact:

San Francisco, California 94143
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.