Efficacy and Safety of Sirolimus in Combination With Tacrolimus

Study Overview
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Brief Summary
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To study the efficacy and safety of the administration of Tacrolimus in combination with Sirolimus for the prevention of acute rejection in patients after renal transplantation

Detailed Description
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Basic randomized clinical trial (multicentre) in primary KTX to assess the safety and efficacy of a tac/rapa vs a tac/MMF regimen. Tac trough levels in accordance with current standards in both arms. Steroids to be used to individual centre protocol. Rapa trough levels will be adjusted to 5-10 ng/ml. Up to now only few data (primate and clinical) on tac/rap combinations available.

Official Title
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A Randomized Multicenter Study to Compare Tacrolimus and MMF With Tacrolimus and Rapamycin in Patients After Renal Transplantation

Conditions
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Kidney Transplantation

Intervention / Treatment
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* Drug: Sirolimus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: first kidney transplantation re-transplantation non-related living donor transplantation patients > 18 years patients have given their written consent after being informed female patients in the age of parity must consent to an effective birth control and submit a negative pregnancy test Exclusion Criteria: related living donation patients with known HIV-anamnesis patients who need systemically administered immunosuppression for another indication than the prophylaxis of kidney graft rejection patients with present malignant disease patients with clinically significant, uncontrolled infectional disease and/or severe diarrhea, vomiting or active gastric ulcer patients who haven taken part in a clinical study in the past 28 days and/or receive (received) medication which is not licensed by the responsible health authority other reasons which depend on the assessment of the physician

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sirolimus|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - time to first biopsy proven acute rejection episode at month 12 |  |  | 
| - graft failure at month 12 |  |  | 
| - discontinuation of study medication at month 12 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - patient and graft survival at month 12 |  |  | 
| - incidence and severity of biopsy proven acute rejection episodes and incidence of steroid-resistant acute rejection episodes at month 12 |  |  | 
| - Renal function at month 12 (S-creatinine, Cockgroft-Gault clearance) |  |  | 
| - incidence and severity of infections at month 12 |  |  | 
| - incidence of adverse events at month 12 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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renal transplantation, immunosuppression, prevention of acute rejection