CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 802 enrolled
Drug / intervention
Everolimus +3 moredrug
Likely dose
Everolimus 1.5 mg/day initially then titrated to target blood level (5-10 ng/mL in CNI-free regimen, 3-8 ng/mL in CNI-low regimen); Mycophenolate sodium up to 1440 mg/day (2 x 720 mg); Cyclosporine dosed according to blood level; Basiliximab 2 x 20 mg IV (Day 0 and Day 4)AI-extracted
Key inclusion· 4
  • ✓Males or females aged 18-70 years
  • ✓Recipients of de novo cadaveric, living unrelated, or living related kidney transplants
  • ✓Females of childbearing potential must have negative serum pregnancy test within 7 days prior to/at screening
  • ✓Written informed consent required
Key exclusion· 5
  • ✕More than one previous renal transplantation
  • ✕Multi-organ recipients (e.g., kidney and pancreas) or previous transplant with organ other than kidney
  • ✕Kidney from non-heart beating donor
  • ✕Donor age <5 years or >70 years

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

Search/NCT00514514
NCT00514514Phase 3Completed
CompareCT.gov

Multi-center, Open-label, Prospective, Randomized, Parallel Group, Long-term Study Investigating a Standard Regimen in de Novo Kidney Transplant Patients Versus a CNI-free Regimen and a CNI-low Dose Regimen

Novartis Pharmaceuticals·interventional·Posted Aug 10, 2007·Updated Jan 18, 2017

In Brief

A Phase 3 clinical trial evaluating Everolimus, Myfortic, and 2 other interventions for Kidney Transplantation. Completed, enrolled 802 participants across 18 sites in 2 countries.

Detailed Summary

The purpose of this study is to compare renal function of immunosuppressive regimens with different relevance of the calcineurin inhibitor (CNI) cyclosporine: standard dose CNI, low dose CNI, CNI free in de novo kidney transplant patients after 12 months of therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Transplantation
CountriesGermany, Switzerland
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 10, 2007
Enrollment StartJul 1, 2007
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 7.9 yearsPosted 18.9 years ago

Interventions

Everolimusdrug

Tablet containing 0.5 mg or 0.75 mg. Dosing schedule: Initially 1.5 mg/day, then based on blood level (5-10 ng/mL in CNI free, 3-8 ng/mL in CNI low regimen

Myforticdrug

1 tablet containing 180 mg or 360 mg Dosing schedule: Initially 1.5 mg/day, then based on blood level (5-10 ng/mL in CNI free, 3-8 ng/mL in CNI low regimen) According to blood level 1440 mg/day (2 x 720 mg), if tolerated. Dose reduction possible in case of side effects (min. dose at BL2 (Month 3): 720 mg/day)

Sandimmun Optoraldrug

1 capsule containing 10, 25, 50, or 100mg. Dosing: According to blood level

Simulect®drug

Lyophilisate in vials with ampoules of sterile water for injection (5 ml). Dosing: 1 vial containing 20 mg lyophilisate. Dosing schedule: 2 x 20 mg to be applied as 10 sec. bolus injection, i.v. on Day 0 (2 h before transplant) and on Day 4