Kidney Graft Function Under the Immunosuppression Strategies

PHASE4CompletedINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

June 30, 2011

Primary Completion Date

August 31, 2013

Study Completion Date

August 31, 2013

Conditions
Chronic Renal Disease
Interventions
DRUG

Standard Dose of Myfortic and Reduced Dose of Myfortic

Low Dose of Neoral (Cyclosporine) and Standard Dose of Myfortic (Enteric-Coated Mycophenolate Sodium) vs. with Conventional Dose of Neoral (Cyclosporine) and Reduced Dose of Myfortic (Enteric-Coated Mycophenolate Sodium)

DRUG

Prednisolone OR methylprednisolone OR deflazacort injected both control group and experimental group

500 mg IV Injection in OP Day and 250 mg IV injection in POD1(1 Post op day). And then the drug dose is gradually reduced following the study institution's protocol. But the subject must be take the dose of 5mg of the drug per one day. The drug dose should be controlled on the basis of 5mg of Prednisolone. It can be used with the same dose of methylprednisolone 4 mg or deflazacort 6 mg.

DRUG

Basiliximab injected both control group and experimental group

The subject must be injected 20 mg of Simulect in Kidney transplantation day and just before the OP. After 4 days(96hour ± 12hr), the subject must be injected 20mg of Simulect, again.

All Listed Sponsors
lead

Samsung Medical Center

OTHER

NCT01817322 - Kidney Graft Function Under the Immunosuppression Strategies | Biotech Hunter | Biotech Hunter