Comparison of Safety and Efficacy of de Novo Everolimus

Not Applicable

Completed

• Conditions: Cytomegalovirus Infections
• Interventions: Drug: Everolimus Pill; Drug: Sandimmun (Neoral) dose plus cellcept

• Registration Number: NCT04906304
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief 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.

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2020-07-01
• Study Completion: 2020-08-01
• Status Verified: 2021-05
• Study First Submitted: 2021-05-25
• Study First Submitted QC: 2021-05-27
• Last Update Submitted: 2021-05-27
• Study First Posted: 2021-05-28
• Last Update Posted: 2021-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Adult Transplanted patients > 18 years

Exclusion Criteria

• Simultanous Kidney -Pancreas Transplantation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Evrolimus	Sandimmun (Neoral) dose plus cellcept	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
Control	Everolimus Pill	0.75 mg/bid everolimus with everolimus C0 3-8 ng/mL plus Sandimmun (Neoral)standard dose plus cellcept
Evrolimus	Everolimus Pill	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
Control	Sandimmun (Neoral) dose plus cellcept	0.75 mg/bid everolimus with everolimus C0 3-8 ng/mL plus Sandimmun (Neoral)standard dose plus cellcept

Primary Outcome Measures

Name	Time	Method
CMV Infection	6 months	CMV PCR quantitative count

Trial Locations

Locations (1)

Nooshin Dalili; 🇮🇷 Tehran, Iran, Islamic Republic of