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

University of Cincinnati

Status and phase

Completed

Phase 4

Conditions

Primary Renal Allograft

Treatments

Drug: sirolimus

Drug: mycophenolate mofetil

Study type

Interventional

Funder types

Other

Identifiers

NCT00374647

STN INV INT

Details and patient eligibility

About

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.

Enrollment

17 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.