NCT04906304

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 28, 2021

Completed
Last Updated

May 28, 2021

Status Verified

May 1, 2021

Enrollment Period

6 months

First QC Date

May 25, 2021

Last Update Submit

May 27, 2021

Conditions

Cytomegalovirus Infections

Outcome Measures

Primary Outcomes (1)

  • CMV Infection

    CMV PCR quantitative count

    6 months

Study Arms (2)

Evrolimus

EXPERIMENTAL

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 PillDrug: Sandimmun (Neoral) dose plus cellcept

Control

ACTIVE COMPARATOR

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

Drug: Everolimus PillDrug: Sandimmun (Neoral) dose plus cellcept

Interventions

Everolimus PillDRUG

standard dose versus low dose Sandimun

Also known as: Novartis
ControlEvrolimus
Sandimmun (Neoral) dose plus cellceptDRUG

Sandimmun (Neoral) dose plus cellcept

ControlEvrolimus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult Transplanted patients \> 18 years

You may not qualify if:

  • Simultanous Kidney -Pancreas Transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nooshin Dalili

Tehran, Iran

Location

MeSH Terms

Conditions

Cytomegalovirus Infections

Interventions

EverolimuslactitolCyclosporineMycophenolic Acid

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic ChemicalsCyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsCaproatesAcids, AcyclicCarboxylic AcidsFatty AcidsLipids

Study Officials

  • SBMU University of Medical Sciences

    Shahid Beheshti University of Medical Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant Professor of SBMU

Study Record Dates

First Submitted

May 25, 2021

First Posted

May 28, 2021

Study Start

January 1, 2020

Primary Completion

July 1, 2020

Study Completion

August 1, 2020

Last Updated

May 28, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)