Study to Evaluate Safety and Efficacy of Early Calcineurin Inhibitor Withdrawal in Primary Renal Allografts

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Evaluate the safety and efficacy of early corticosteroid withdrawal and simultaneous calcineurin inhibitor withdrawal in recipients of primary renal allografts maintained long-term on MMF and sirolimus.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cincinnati
• Treatments: Calcineurin Inhibitors; Everolimus; Mycophenolate mofetil; Mycophenolic Acid; Sirolimus

Criteria

Inclusion Criteria:

• Male and female patients between 18 and 75 years of age.

• Patients who are 90 to 240 days after having received a primary living or cadaver renal allograft.

• Patients maintained on a regimen of cyclosporine or tacrolimus and MMF since transplantation.

• Capable of providing written informed consent.

• No known contraindications to treatment with sirolimus.

Exclusion Criteria:

• Pregnant or lactating.

• Acute rejection within 90 days prior to study randomization.

• More than one biopsy proven acute rejection episode prior to study randomization.

• Previously received or are receiving an organ transplant other than kidney.

• Receiving sirolimus prior to entry.

• Severe diarrhea or other gastrointestinal disorders that may interfere with their ability to absorb oral medication.

• Evidence of active systemic infection requiring antibiotics, or HIV, HCV, HBV infection.

• History of malignancy in the past 5 years.

• Require dialysis at the time of study entry.