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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

830 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2008-05-31

Brief Summary

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

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Detailed Description

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Conditions

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Renal Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Conversion from calcineurin inhibitor immunosuppression to Sirolimus-based immunosuppression

Group Type ACTIVE_COMPARATOR

Sirolimus

Intervention Type DRUG

Sirolimus, Cyclosporine A \& Tacrolimus are concentration controlled

tacrolimus

Intervention Type DRUG

Cyclosporine A

Intervention Type DRUG

B

Continued calcineurin inhibitor therapy

Group Type ACTIVE_COMPARATOR

Sirolimus

Intervention Type DRUG

Sirolimus, Cyclosporine A \& Tacrolimus are concentration controlled

tacrolimus

Intervention Type DRUG

Cyclosporine A

Intervention Type DRUG

Interventions

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Sirolimus

Sirolimus, Cyclosporine A \& Tacrolimus are concentration controlled

Intervention Type DRUG

tacrolimus

Intervention Type DRUG

Cyclosporine A

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No