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

Completed · Phase 4

Conditions studied: Primary Renal Allograft

In brief

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.

Key facts

Study ID

NCT00374647

Run by

University of Cincinnati

People needed

17

Starts

2005-03-01

Expected to finish

2007-12-01

Last updated by the study team

2021-07-15

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The Christ Hospital — Cincinnati, Ohio, United States
• University of Cincinnati — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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