At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 300 enrolled

Drug / intervention

Everolimus +3 moredrug

Likely dose

Everolimus tablets orally twice daily to maintain 6-10 ng/mL; Enteric-coated mycophenolate sodium 1440 mg/day (minimum 720 mg/day); Cyclosporine tablets orally twice daily to protocol-specific target levels; Corticosteroids minimum 5 mg prednisolone or equivalent dailyAI-extracted

Key inclusion· 4

✓Age 18-65 years
✓Recipients of de novo cadaveric, living unrelated, or living related kidney transplant
✓On EC-MPS (720-1440 mg/day), cyclosporine, and corticosteroids at randomization (BL 2)
✓Serum creatinine ≤3.0 mg/dL at randomization

Key exclusion· 10

✕More than one previous renal transplantation
✕Multi-organ recipients or previous non-kidney transplant
✕Graft loss due to immunological reasons in first year after prior transplant
✕ABO-incompatible transplant recipients

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

Search/NCT00154310

NCT00154310Phase 4Completed

Compare CT.gov

Multi-center, Open-label, Prospective, Randomized, Parallel Group Study Investigating a CNI-free Regimen With Enteric-Coated Mycophenolate Sodium (EC-MPS) and Everolimus in Comparison to Standard Therapy With Enteric-Coated Mycophenolate Sodium (EC-MPS) and Cyclosporine Microemulsion in de Novo Renal Transplant Patients

Novartis·interventional·Posted Sep 12, 2005·Updated Nov 13, 2013

In Brief

A Phase 4 clinical trial evaluating Everolimus, Cyclosporine, and 2 other interventions for Renal Transplantation. Completed, enrolled 300 participants across 3 sites in 2 countries.

Detailed Summary

The purpose of this study is to assess whether a calcineurin inhibitor (CNI)-free regimen with enteric-coated mycophenolate sodium (EC-MPS) and everolimus is as safe and well-tolerated as the standard regimen containing enteric-coated mycophenolate sodium (EC-MPS) and cyclosporine microemulsion, but results in better renal function.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsRenal Transplantation

CountriesGermany, Switzerland

Collaborators--

Timeline

Phase 4CompletedFinished

20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJun 2005

First PostedSep 2005

Primary CompletionSep 2008

TodayJul 2026

First PostedSep 12, 2005

Enrollment StartJun 1, 2005

Primary CompletionSep 1, 2008

TodayJul 2, 2026

Enrollment to primary: 3.3 yearsPosted 20.8 years ago

Interventions

Everolimusdrug

Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL.

Cyclosporinedrug

Tablets orally twice a day to maintain protocol specific target blood levels

Enteric-coated mycophenolate sodiumdrug

Enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day.

Corticosteroidsdrug

Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5mg prednisolone or equivalent and had to be continued throughout the first year.