Efficacy and Safety of Enteric-coated Mycophenolate Sodium and Cyclosporine in Combination With and Without Steroids, in Adult Renal Transplant Recipients

PHASE3CompletedINTERVENTIONAL
Enrollment

222

Participants

Timeline

Start Date

April 30, 2007

Primary Completion Date

March 31, 2009

Conditions
Renal Transplantation
Interventions
DRUG

Enteric-coated mycophenolate sodium (EC-MPS)

An initial dose of 1080 mg EC-MPS was administered immediately before transplantation. Then, during the first 6 weeks post-transplantation, EC-MPS was administered at a dose of 1080 mg twice a day 12 hours apart. From week 7 until the end of the study (month 6), EC-MPS was administered at standard dose of 720 mg twice a day.

DRUG

Prednisone

Oral tablets

Trial Locations (1)

Unknown

C.H.U. La Milétrie, Poitiers

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novartis

INDUSTRY

NCT00413920 - Efficacy and Safety of Enteric-coated Mycophenolate Sodium and Cyclosporine in Combination With and Without Steroids, in Adult Renal Transplant Recipients | Biotech Hunter | Biotech Hunter