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Comparison of Safety and Efficacy of de Novo Everolimus

NCT ID: NCT04906304

Last Updated: 2021-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2020-08-01

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.

Conditions

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Cytomegalovirus Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Evrolimus

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

Group Type EXPERIMENTAL

Everolimus Pill

Intervention Type DRUG

standard dose versus low dose Sandimun

Sandimmun (Neoral) dose plus cellcept

Intervention Type DRUG

Sandimmun (Neoral) dose plus cellcept

Control

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

Group Type ACTIVE_COMPARATOR

Everolimus Pill

Intervention Type DRUG

standard dose versus low dose Sandimun

Sandimmun (Neoral) dose plus cellcept

Intervention Type DRUG

Sandimmun (Neoral) dose plus cellcept

Interventions

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Everolimus Pill

standard dose versus low dose Sandimun

Intervention Type DRUG

Sandimmun (Neoral) dose plus cellcept

Sandimmun (Neoral) dose plus cellcept

Intervention Type DRUG

Other Intervention Names

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Novartis

Eligibility Criteria

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Inclusion Criteria

* Adult Transplanted patients \> 18 years

Exclusion Criteria

* Simultanous Kidney -Pancreas Transplantation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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nooshin dalili

assistant Professor of SBMU

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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SBMU University of Medical Sciences

Role: STUDY_DIRECTOR

Shahid Beheshti University of Medical Sciences

Locations

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Nooshin Dalili

Tehran, , Iran

Site Status

Countries

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Iran

Other Identifiers

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UNRC940401/18

Identifier Type: -

Identifier Source: org_study_id