Status:
WITHDRAWN
Pilot Trial to Assess Effect of CNI Conversion of Efalizumab on T Reg Cells
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Autoimmune Diseases
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00777400
Start Date
December 1 2008
End Date
April 1 2009
Last Update
May 14 2013
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94143