Study Comparing Conversion to Sirolimus vs. Continued Use of Calcineurin Inhibitors in Kidney Transplant Recipients

Wyeth

Status and phase: Completed; Phase 3

Conditions: Renal Transplantation

Treatments: Drug: Sirolimus; Drug: tacrolimus; Drug: Cyclosporine A

Study type: Interventional

Funder types: Industry

Identifiers

NCT00038948

0468H1-316

Details and patient eligibility

About

The purpose of this study is to determine the effect of conversion from calcineurin inhibitor to sirolimus based therapy on renal function.

Enrollment: 830 patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age greater than or equal to 13 years.
• Receiving CsA or tacrolimus from the time of transplantation or within 2 weeks thereafter
• Patients with a functioning allograft and a Nankivell GFR greater than or equal to 20 mL/min, within 2 weeks before randomization

Exclusion criteria

• Biopsy-confirmed acute rejection within 12 weeks before randomization, that was determined to require antirejection treatment
• Patients in whom kidney-pancreas or other multiple organ transplants have been performed

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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830 participants in 2 patient groups

A

Active Comparator group

Description:

Conversion from calcineurin inhibitor immunosuppression to Sirolimus-based immunosuppression

Treatment:

Drug: Sirolimus

Drug: tacrolimus

Drug: Cyclosporine A

B

Active Comparator group

Description:

Continued calcineurin inhibitor therapy

Treatment:

Drug: Sirolimus

Drug: tacrolimus

Drug: Cyclosporine A