NCT04906304

Comparison of Safety and Efficacy of de Novo Everolimus

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Shahid Beheshti University of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Cytomegalovirus Infections

Interventions

Type	Name	Description
DRUG	Everolimus Pill	standard dose versus low dose Sandimun
DRUG	Sandimmun (Neoral) dose plus cellcept	Sandimmun (Neoral) dose plus cellcept

Timeline

• Start date: 2020-01-01
• Primary completion: 2020-07-01
• Completion: 2020-08-01
• First posted: 2021-05-28
• Last updated: 2021-05-28

Locations

1 site across 1 country: Iran