NCT00452361 - Study Evaluating of Calcineurin Inhibitors Versus Sirolimus in Renal Allograft Recipient | Crick

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

31

Conditions

Kidney Transplantation

Interventions

Sirolimus+MMF or MPS or AZA+SteroidDRUG

Corticosteroids will be administered according to local practice, within a daily maintenance dosage range of 2.5 to15 mg for prednisone or prednisolone (2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.

Calcineurin Inhibitors (either cyclosporine or tacrolimus)+MMF or MPS or AZA+SteroidDRUG

The maintenance dose of: 1. MMF will not exceed 1500 mg/day or PMS will not exceed 1080 mg/day 2. AZA will not exceed 75 mg/day Thereafter, at the discretion of the investigator, MMF/MPS or AZA may be: 1. continued for the entire 104-week period of randomized therapy 2. subsequently discontinued 3. restarted after discontinuation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Select Cities, Taiwan

Outcomes

Primary Outcomes

Change in Glomerular Filtration Rate (GFR) Change From Baseline

GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. GFR was calculated using Nankivell formula. A normal GFR is \> 90 mL/min, although children and older people usually have a lower GFR. Lower values indicate poor kidney function. A GFR \<15 is consistent with kidney failure.

Time frame: 104 weeks

Secondary Outcomes

Change in Glomerular Filtration Rate (GFR)

GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. GFR was calculated using Nankivell formula. A normal GFR is \> 90 mL/min, although children and older people usually have a lower GFR. Lower values indicate poor kidney function. A GFR \<15 is consistent with kidney failure.

Time frame: Baseline and Week 24

Change in Glomerular Filtration Rate (GFR)

GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. GFR was calculated using Nankivell formula. A normal GFR is \> 90 mL/min, although children and older people usually have a lower GFR. Lower values indicate poor kidney function. A GFR \<15 is consistent with kidney failure.

Time frame: Baseline and Week 52

Change in Glomerular Filtration Rate (GFR)

GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. GFR was calculated using Nankivell formula. A normal GFR is \> 90 mL/min, although children and older people usually have a lower GFR. Lower values indicate poor kidney function. A GFR \<15 is consistent with kidney failure.

Time frame: Baseline and Week 104