CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 1,209 enrolled
Drug / intervention
Sirolimus +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03468478
NCT03468478Phase 4Completed
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Comparison of the Efficacy and Safety of Sirolimus, Everolimus or Mycophenolate in Renal Transplant Recipients Receiving Induction With Anti-thymocyte Globulin, Tacrolimus and Prednisone

Hospital do Rim e Hipertensão·interventional·Posted Mar 16, 2018·Updated Apr 24, 2023

In Brief

A Phase 4 clinical trial evaluating Sirolimus, Everolimus, and 1 other intervention for Kidney Transplant Infection. Completed, enrolled 1,209 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Transplant Infection
CountriesBrazil
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedMar 16, 2018
Enrollment StartJun 18, 2017
Primary CompletionMar 18, 2021
Study CompletionAug 23, 2021
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 8.3 years ago

Interventions

Sirolimusdrug

sirolimus combined to reduced dose of tacrolimus

Everolimusdrug

everolimus combined to reduced dose of tacrolimus

Mycophenolic aciddrug

Control arm: mycophenolate combined to regular tacrolimus