CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 139 enrolled
Drug / intervention
Everolimus (RAD001)drug
Likely dose
Not stated in record
Key inclusion· 2
  • ✓Recipients of cadaveric kidney transplants
  • ✓At risk of DGF: donor age >55 years, OR cold ischemic time (CIT) ≥24 but <40 hours, OR second or subsequent renal transplantation
Key exclusion· 3
  • ✕Multiple organ transplants or more than one kidney transplant, or prior transplant with any organ other than kidney
  • ✕Body mass index (BMI) >32 kg/m²
  • ✕Investigational drug within 4 weeks of baseline

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

Search/NCT00154297
NCT00154297Phase 4Completed
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A National Multicentre Randomized Study Comparing the Early Versus Delayed Administration of Everolimus in de Novo Kidney Transplant Recipients at Risk of Delayed Graft Function

Novartis Pharmaceuticals·interventional·Posted Sep 12, 2005·Updated Apr 4, 2011

In Brief

A Phase 4 clinical trial evaluating Everolimus (RAD001) for Renal Transplantation. Completed, enrolled 139 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate if the delayed administration of everolimus could reduce the everolimus associated "anti-proliferative complications" (e.g. wound healing disorder) while maintaining efficacy, when compared to the immediate administration of everolimus in de novo renal transplant patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Transplantation
CountriesSwitzerland
Collaborators--

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 12, 2005
Enrollment StartJun 1, 2005
Primary CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 20.8 years ago

Interventions

Everolimus (RAD001)drug