CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 30 enrolled
Drug / intervention
Everolimusdrug
Likely dose
Not stated in record
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Search/NCT01239472
NCT01239472Phase 4Completed

Cytokines Evaluation in Early Calcineurin Inhibitors Withdrawn on Renal Transplant

Andre Barreto Pereira·interventional·Posted Nov 11, 2010·Updated Feb 7, 2020

In Brief

A Phase 4 clinical trial evaluating Everolimus for Renal Transplant Rejection and Immunosuppression. Completed, enrolled 30 participants across 1 site.

Detailed Summary

Currently, acute kidney injury is diagnosed by increased serum creatinine. However, creatinine is not a reliable marker for acute changes in renal function. The biology of the renal graft is influenced by chemokines from reperfusion (just after the kidney transplant) and throughout its course, when acute and chronic inflammatory changes occurs. Moreover, the evaluation of changes in urinary cytokines reflects kidney interstitial patterns, and can predict renal function, acute rejection episodes and their response to treatment. Today there are several studies comparing the relative immunosuppression of renal function, but few noticed its relationship with cytokines and chemokines. Thus, we proposed studying the inflammatory consequences of early calcineurin inhibitors (ICN) withdrawing in transplant patients by urine analysis. Kidney biopsy was done before ICN withdrawn and replaced by everolimus (3 months after transplant), and 1 year after transplant.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil
CollaboratorsNovartis

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 11, 2010
Enrollment StartJan 1, 2011
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 15.6 years ago

Interventions

Everolimusdrug

Replacement of tacrolimus by everolimus, 30 days after transplat. It was done after kidney biopsy (excluding acute rejection), blood and urine analysis.