Pilot Trial to Assess Effect of CNI Conversion of Efalizumab on T Reg Cells

Withdrawn before enrolling · Phase 1/Phase 2

Conditions studied: Autoimmune Diseases

In brief

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.

Key facts

Study ID

NCT00777400

Run by

University of California, San Francisco

People needed

0

Starts

2008-12-01

Expected to finish

2009-04-01

Last updated by the study team

2013-05-14

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of California, San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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