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

Study Overview
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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.

Official Title
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A Randomized, Open-label, Comparative Evaluation of Conversion From Calcineurin Inhibitors to Sirolimus Versus Continued Use of Calcineurin Inhibitors in Renal Allograft Recipients

Conditions
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Renal Transplantation

Intervention / Treatment
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* Drug: Sirolimus
* Drug: tacrolimus
* Drug: Cyclosporine A


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Conversion from calcineurin inhibitor immunosuppression to Sirolimus-based immunosuppression | Drug: Sirolimus<br>* Sirolimus, Cyclosporine A & Tacrolimus are concentration controlled<br>Drug: tacrolimus<br> <br> Drug: Cyclosporine A<br> <br> |
| Active Comparator: B<br>Continued calcineurin inhibitor therapy | Drug: Sirolimus<br>* Sirolimus, Cyclosporine A & Tacrolimus are concentration controlled<br>Drug: tacrolimus<br> <br> Drug: Cyclosporine A<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nankivell Glomerular Filtration Rate (GFR) | Nankivell GFR: patients with baseline GFR of 20.0 to 40.0 mL/min and patients with baseline GFR of greater than 40.0 mL/min. GFR is an index of kidney function. A higher value means better kidney function. | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First Occurrence of Biopsy-confirmed Acute Rejection, Graft Loss, or Death. | Number of patients who experienced for the first time either biopsy-confirmed acute rejection, graft loss, or death by weeks 52 and 104. Assessed by individual endpoint and as composite endpoint (all combined). | 52 and 104 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal, Allograft, Recipients