Planned Conversion From TAC to SRL-based Regimen in de Novo Kidney Transplant Recipients

Study Overview
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Brief Summary
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Background Early conversion from calcineurin inhibitor to mammalian target of rapamycin inhibitor is one of the immunosuppressive strategies that have been investigated to mitigate long-term CNi associated adverse events. This study aims to evaluate the conversion from tacrolimus to sirolimus in de novo kidney transplant recipients. This multicenter, open-label study, planned to enroll 297 patients initially treated with tacrolimus, enteric-coated mycophenolate sodium (1440 mg/day, orally) and prednisone. The primary objective is to show superior glomerular filtration rate in the SRL group at 24 months after transplantation.

Official Title
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Outcomes of Planned Conversion From Tacrolimus to Sirolimus-based Immunosuppressive Regimen in de Novo Kidney Transplant Recipients

Conditions
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Kidney Transplant

Intervention / Treatment
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* Drug: Conversion from Tacrolimus to Sirolimus
* Drug: Maintenance on tacrolimus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients older than 18 years, recipients of first kidney transplant from brain dead deceased or living related non-HLA identical donors not older than 65 years, patients had to receive an ABO compatible organ with a CDC negative crossmatch and a peak panel reactive antibody lower that 30%, all patients agreed to use contraceptive methods during the study and up to 3 months after study drug discontinuation. Exclusion Criteria: patients with chronic kidney diseases due to focal and segmental glomerulosclerosis and membranoproliferative glomerulonephritis, patients with active infection or positive for hepatitis B or C or human immunodeficiency viruses, patients with previous history of malignancy, patients with significant hematological or metabolic laboratorial abnormalities.

Ages Eligible for Study
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Minimum Age: 18 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: Sirolimus<br>Conversion from Tacrolimus to Sirolimus | Drug: Conversion from Tacrolimus to Sirolimus<br> <br> |
| Active Comparator: Tacrolimus<br>Maintenance on tacrolimus | Drug: Maintenance on tacrolimus<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal Function calculated using the 4 variable MDRD formula |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival free from first treated biopsy confirmed acute rejection episodes (tBCAR) > IA according to Banff 1997 classification. |  | 24 months | 
| Incidence of all treated acute rejections. |  | 24 months | 
| Incidence and severity of all tBCAR. |  | 24 months | 
| Patient and graft survival. |  | 24 months | 
| Incidence of treatment discontinuation |  | 24 months | 
| Incidence of adverse events. |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sirolimus, tacrolimus, early conversion