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Comparison of the Efficacy and Safety of Sirolimus Versus Everolimus Versus Mycophenolate in Kidney Transplantation

NCT03468478 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1209

Last updated 2023-04-24

Study results available
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Summary

This study was designed to compare 3 immunosuppression regimens: sirolimus and tacrolimus versus everolimus and tacrolimus versus mycophenolate and tacrolimus.

The primary outcome is the incidence of cytomegalovirus infection / disease, a relevant medical need in the absence of pharmacological prophylaxis.

Conditions

  • Kidney Transplant Infection

Interventions

DRUG

Sirolimus

sirolimus combined to reduced dose of tacrolimus

DRUG

Everolimus

everolimus combined to reduced dose of tacrolimus

DRUG

Mycophenolic acid

Control arm: mycophenolate combined to regular tacrolimus

Sponsors & Collaborators

  • Hospital do Rim e Hipertensão

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-18
Primary Completion
2021-03-18
Completion
2021-08-23
FDA Drug
Yes

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03468478 on ClinicalTrials.gov