Study Of The Safety And Efficacy Of Conversion From A CNI To Sirolimus In Renally-Impaired Heart Transplant Recipients

Wyeth

Status and phase: Completed; Phase 4

Conditions: Kidney Failure; Graft Rejection

Treatments: Drug: cyclosporine or tacrolimus; Drug: sirolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT00369382

0468E7-408

B1741006 (Other Identifier)

Details and patient eligibility

About

The primary purpose of this study is to determine whether converting from calcineurin inhibitor (CNI) therapy to sirolimus therapy will be more effective than continuing calcineurin inhibitor therapy with respect to renal function in cardiac transplant recipients with mild to moderate renal dysfunction.

Enrollment: 121 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cardiac transplant recipients age 18 years or older receiving cyclosporine or tacrolimus since the time of transplant.
• 12 months after cardiac transplantation but less than 96 months post-transplantation.

Exclusion criteria

• Multiple-organ transplant recipients (such as heart-lung, heart-kidney, or heart after kidney transplant recipients).
• Prior or current use of sirolimus or everolimus unless administration was part of a "CNI holiday" lasting no more than 10 days.
• History of acute rejection within the last 3 months, malignancy within the last 5 years (except for adequately treated basal cell or squamous cell carcinoma of the skin), and human immunodeficiency virus (HIV) patients.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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121 participants in 2 patient groups

1

Active Comparator group

Description:

Group 1: Continuation of CNI regimen

Treatment:

Drug: cyclosporine or tacrolimus

2

Experimental group

Description:

Group 2: (CNI-Free) Conversion to SRL-based regimen

Treatment:

Drug: sirolimus