CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 114 enrolled
Drug / intervention
Everolimus (Certican) +3 moredrug
Likely dose
Everolimus (dose not specified in INTERVENTIONS or ARMS)AI-extracted
Key inclusion· 3
  • ✓First renal transplant from primary cadaveric or non-HLA identical living related donor
  • ✓Renal cold ischemic time less than 36 hours
  • ✓Donor age less than 65 years
Key exclusion· 3
  • ✕Received investigational drug within 4 weeks of baseline
  • ✕Recipients of multiple organ transplants (organ other than kidney)
  • ✕Recipients of non-heart beating donor organs

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

Search/NCT00154284
NCT00154284Phase 3Completed
CompareCT.gov

A 12 Month, Multicenter, Randomized, Parallel, Open-label Study, to Evaluate Renal Function and Efficacy of Everolimus With Basiliximab and Cyclosporine Microemulsion Discontinuation at 3 Month Post-transplant Versus Minimization, in de Novo Kidney Transplant Recipients

Novartis·interventional·Posted Sep 12, 2005·Updated Aug 9, 2018

In Brief

A Phase 3 clinical trial evaluating Everolimus (Certican), Cyclosporine (Neoral), and 2 other interventions for Organ Transplantation, Renal Transplantation. Completed, enrolled 114 participants.

Detailed Summary

The purpose of this study is to evaluate the safety and efficacy of everolimus in combination with basiliximab, and steroids with and without cyclosporine microemulsion in de novo kidney transplant recipients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOrgan Transplantation, Renal Transplantation
Countries--
Collaborators--

Timeline

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

Interventions

Everolimus (Certican)drug

Cyclosporine (Neoral)drug

Steroiddrug

Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.

Basiliximab (Simulect)drug