Comparison of Safety and Efficacy of de Novo Everolimus

Study Overview
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Brief Summary
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Nowadays, de novo everolimus regimen in renal transplant patients is considered for reduction of cyclosporine dose and it is mentioned that this regimen not only has similar safety and efficacy, but also could prevent Cytomegalovirus (CMV )infections. So, the aim of this study was comparison of safety and efficacy of de novo everolimus plus low dose of cyclosporine with standard dose of cyclosporine plus cellcept on CMV virus infections prevention in renal transplant patients.

Detailed Description
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This randomized clinical trial was conducted in Shahid Labbafi nejad hospital. 35 renal transplanted patients enter the study and randomized to one of two groups: everolimus or control (Sandimmun or tacrolimus). However, 34 patients completed study (17 patients in each group). The treatment regimen in everolimus group was 0.75 mg/bid everolimus with everolimus C0 3-8 ng/mL plus Sandimmun (Neoral) low dose and in control group was standard dose of Sandimmun or tacrolimus plus cellcept. All patients gave Antithymocyte Glubolin and prednisolone. In addition, they gave CMV prophylaxis until 3 months. Kidney biopsies were done for raise of creatinine or protocol biopsy at 6 month after transplantation. Demographic, renal disease and transplantation characteristics, CMV and BK virus status, rejection, and routine laboratory tests recorded during study period and compared between two groups.

Official Title
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Comparison of Safety and Efficacy of de Novo Everolimus Plus Low Dose of Cyclosporine With Standard Dose of Cyclosporine Plus Cellcept on CMV and BK Virus Infections Prevention in Renal Transplant Patients

Conditions
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Cytomegalovirus Infections

Intervention / Treatment
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* Drug: Everolimus Pill
* Drug: Sandimmun (Neoral) dose plus cellcept


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult Transplanted patients > 18 years Exclusion Criteria: Simultanous Kidney -Pancreas Transplantation

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Evrolimus<br>The treatment regimen in everolimus group was 0.75 mg/bid everolimus with everolimus C0 3-8 ng/mL plus Sandimmun (Neoral) low dose pluse cellcept | Drug: Everolimus Pill<br>* standard dose versus low dose Sandimun<br>* Other names: Novartis;Drug: Sandimmun (Neoral) dose plus cellcept<br>* Sandimmun (Neoral) dose plus cellcept<br>|
| Active Comparator: Control<br>0.75 mg/bid everolimus with everolimus C0 3-8 ng/mL plus Sandimmun (Neoral)standard dose plus cellcept | Drug: Everolimus Pill<br>* standard dose versus low dose Sandimun<br>* Other names: Novartis;Drug: Sandimmun (Neoral) dose plus cellcept<br>* Sandimmun (Neoral) dose plus cellcept<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CMV Infection | CMV PCR quantitative count | 6 months |