Study Evaluating of Calcineurin Inhibitors Versus Sirolimus in Renal Allograft Recipient

Wyeth

Status and phase: Terminated; Phase 4

Conditions: Kidney Transplantation

Treatments: Drug: Calcineurin Inhibitors (either cyclosporine or tacrolimus)+MMF or MPS or AZA+Steroid; Drug: Sirolimus+MMF or MPS or AZA+Steroid

Study type: Interventional

Funder types: Industry

Identifiers

NCT00452361

0468H-101864

Details and patient eligibility

About

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).

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

1

Experimental group

Description:

Sirolimus therapy

Treatment:

Drug: Sirolimus+MMF or MPS or AZA+Steroid

2

Active Comparator group

Description:

Calcineurin Inhibitor therapy (either cyclosporine or tacrolimus)

Treatment:

Drug: Calcineurin Inhibitors (either cyclosporine or tacrolimus)+MMF or MPS or AZA+Steroid