Evaluation of the Therapeutic Benefit of an Initial Intensified Dosing Regimen of Mycophenolate Sodium Versus a Standard Regimen in Renal Transplant Patients

PHASE4CompletedINTERVENTIONAL
Enrollment

313

Participants

Timeline

Start Date

December 31, 2006

Primary Completion Date

June 30, 2009

Study Completion Date

June 30, 2009

Conditions
Kidney Transplantation
Interventions
DRUG

Enteric-coated mycophenolate sodium (Myfortic)

1440 mg/day for the standard dose. 2880 mg/day for the initial intensified dosage, reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.

DRUG

Cyclosporine (Neoral)

cyclosporine microemulsion in galenic form capsules starting at twice a day for a dose of 8-10 mg/kg/day adjusted if necessary to achieve protocol specific target levels

DRUG

Prednisone

20 mg orally per day reduced according to center practice for a minimum dose of 5 mg/day.

Trial Locations (1)

Unknown

Novartis, Basel

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novartis

INDUSTRY

NCT00419926 - Evaluation of the Therapeutic Benefit of an Initial Intensified Dosing Regimen of Mycophenolate Sodium Versus a Standard Regimen in Renal Transplant Patients | Biotech Hunter | Biotech Hunter