Clinical trial NCT00452361: Study Evaluating of Calcineurin Inhibitors Versus Sirolimus in Renal Allograft Recipient
Official title: A Randomized, Open-label, Comparative Evaluation of Conversion From Calcineurin Inhibitors to Sirolimus Versus Continued Use of Calcineurin Inhibitors in Renal Allograft Recipient
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Kidney Transplantation
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-03-27
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate whether conversion from cyclosporine, a calcineurin inhibitor (CI) to sirolimus (SRL) results in improved long-term renal function without a negative impact on safety or immunosuppressive efficacy, and to further examine the potential of SRL to reduce the severity and/or progression of chronic allograft nephropathy (CAN).

Detailed description: This open-label, randomized, parallel-group, comparative, outpatient study will be conducted in multiple centers in Taiwan.

The study will randomize approximately 120 patients. 80 patients will be randomized to the SRL therapy group (conversion from CI- to SRL-based immunosuppression: group A) and 40 patients to the CI therapy group (continued CI therapy: group B).

Dosage and Administration

SRL Therapy: At the time of randomization on day 1, each patient will have been receiving:

* triple therapy with a CI (tacrolimus or CsA) that began at the time of transplantation or within 2 weeks thereafter AND
* corticosteroids corresponding to a dosage range of 2.5 to 15 mg/day for prednisone or prednisolone (2 to 12 mg/day for methylprednisolone) or the alternate day equivalent for at least 12 weeks before randomization, PLUS
* either MMF (minimum dose 500 mg/day)/MPS (minimum dose 360 mg/day) or AZA (minimum dose 50 mg/day) for at least 12 weeks before randomization.

SRL will be added to the immunosuppressive regimen for Group A. Group B will continue on this CI immunosuppressive regimen.

Eligibility criteria: Inclusion Criteria:

* Subjects must be at least 18 years of age.
* Subjects who are 6 to 60 months after renal transplantation.
* Subjects who have a stable graft function.

Exclusion Criteria:

* Subjects with active major infection, including HIV, decreased platelets, elevated lipids, or multiple organ transplants.

Primary outcomes:
measure: Change in Glomerular Filtration Rate (GFR) Change From Baseline
timeFrame: 104 weeks
Secondary outcomes:
measure: Change in Glomerular Filtration Rate (GFR)
timeFrame: Baseline and Week 24
measure: Change in Glomerular Filtration Rate (GFR)
timeFrame: Baseline and Week 52
measure: Change in Glomerular Filtration Rate (GFR)
timeFrame: Baseline and Week 104
measure: Patient and Graft Survival
timeFrame: Week 24
measure: Patient and Graft Survival
timeFrame: Week 52
measure: Patient and Graft Survival
timeFrame: Week 104
measure: Change From Baseline in Diastolic Blood Pressure at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in Diastolic Blood Pressure at Week 52
timeFrame: Baseline and Week 52
measure: Change From Baseline in Diastolic Blood Pressure at Week 104
timeFrame: Baseline and Week 104
measure: Change From Baseline in Systolic Blood Pressure at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in Systolic Blood Pressure at Week 52
timeFrame: Baseline and Week 52
measure: Change From Baseline in Systolic Blood Pressure at Week 104
timeFrame: Baseline and Week 104
measure: Change From Baseline in the Severity and Progression of Biopsy-Confirmed Chronic Allograft Nephropathy (CAN) at Week 104
timeFrame: Baseline and Week 104
measure: Occurence of Acute Rejection or Premature Withdrawal From Study Medication for Any Reason by Week 52
timeFrame: Weeks 52
measure: Occurence of Acute Rejection or Premature Withdrawal From Study Medication for Any Reason by Week 104
timeFrame: Week 104
measure: Incidence and Severity of Biopsy-Confirmed Acute Rejection at Week 24
timeFrame: Week 24
measure: Incidence and Severity of Biopsy-Confirmed Acute Rejection at Week 52
timeFrame: Week 52
measure: Incidence and Severity of Biopsy-Confirmed Acute Rejection at Week 104
timeFrame: Week 104
Other outcomes:
Locations:
city: Select Cities
country: Taiwan
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References: