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

• Status: Withdrawn
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: Genentech, Inc.
• Treatments: Antibodies, Monoclonal

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