Comparison of Safety and Efficacy of de Novo Everolimus

Shahid Beheshti University of Medical Sciences

Status: Completed

Conditions: Cytomegalovirus Infections

Treatments: Drug: Everolimus Pill; Drug: Sandimmun (Neoral) dose plus cellcept

Study type: Interventional

Funder types: Other

Identifiers

NCT04906304

UNRC940401/18

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult Transplanted patients > 18 years

Exclusion criteria

• Simultanous Kidney -Pancreas Transplantation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

35 participants in 2 patient groups

Evrolimus

Experimental group

Description:

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

Treatment:

Drug: Sandimmun (Neoral) dose plus cellcept

Drug: Everolimus Pill

Control

Active Comparator group

Description:

0.75 mg/bid everolimus with everolimus C0 3-8 ng/mL plus Sandimmun (Neoral)standard dose plus cellcept

Treatment:

Drug: Sandimmun (Neoral) dose plus cellcept

Drug: Everolimus Pill