NCT01169701View on ClinicalTrials.gov

24 Months Follow-up, Two Arm Study to Compare the Cardiovascular Profile in a Regimen With Everolimus + Mycophenolic Acid (MPA) Versus (vs.) a Regimen of CNI+MPA in Maintenance Renal Transplant Recipients

PHASE4CompletedINTERVENTIONAL
Enrollment

71

Participants

Timeline

Start Date

August 31, 2010

Primary Completion Date

March 31, 2014

Study Completion Date

March 31, 2014

Conditions
Renal Transplant
Interventions
DRUG

Everolimus

Everolimus was supplied in boxes with 60 tablets. Available tablets: 1.0 mg, 0.5 mg and 0.25 mg.

DRUG

Tacrolimus

Tacrolimus was administrated as Prograf® or Advagraf®, but could not be changed during study.

DRUG

Mycophenolic acid (MPA)

Myfortic® (MFS) was given as 720-1440 mg/day or 360-1440 mg/day. Cell-Cept® (MMF) was given as 1000-2000 mg/day or 500-2000 mg/day.

Trial Locations (9)

28040

Novartis Investigative Site, Madrid

28041

Novartis Investigative Site, Madrid

29010

Novartis Investigative Site, Málaga

08907

Novartis Investigative Site, L'Hospitalet de Llobregat

08003

Novartis Investigative Site, Barcelona

08025

Novartis Investigative Site, Barcelona

08035

Novartis Investigative Site, Barcelona

08036

Novartis Investigative Site, Barcelona

Unknown

Novartis Investigative Site, Madrid

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY