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

Phase 4

Completed

• Conditions: Primary Renal Allograft

• Registration Number: NCT00374647
• Lead Sponsor: University of Cincinnati

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 sirolimus.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2006-09-08
• Study First Submitted QC: 2006-09-08
• Study First Posted: 2006-09-11
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-08
• Last Update Posted: 2021-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Composite endpoint of either acute rejection, biopsy proven calcineurin inhibitor toxicity, or failure of the estimated BSA indexed GFR by MDRD method to improve by 20% from time randomization to 12 months.

Secondary Outcome Measures

Name	Time	Method
Incidence of biopsy proven acute rejection at 6 and 12 months.
Total number of rejection episodes per patient.
Graft loss and patient death.
Time to first rejection.
Incidence of treatment failure.
Renal allograft function at 6 and 12 months.

Trial Locations

Locations (2)

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

The Christ Hospital; 🇺🇸 Cincinnati, Ohio, United States