Status:
COMPLETED
Study to Evaluate Safety and Efficacy of Early Calcineurin Inhibitor Withdrawal in Primary Renal Allografts
Lead Sponsor:
University of Cincinnati
Conditions:
Primary Renal Allograft
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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 sirolimu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00374647
Start Date
March 1 2005
End Date
December 1 2007
Last Update
July 15 2021
Active Locations (2)
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1
The Christ Hospital
Cincinnati, Ohio, United States, 45267
2
University of Cincinnati
Cincinnati, Ohio, United States, 45267