Study to Evaluate the Safety and Efficacy of Extended Release Tacrolimus (Advagraf®) + Sirolimus (Rapamune®), Versus Extended Release Tacrolimus (Advagraf®) + Mycophenolate Mofetil in Kidney Transplant Patients

PHASE4CompletedINTERVENTIONAL
Enrollment

158

Participants

Timeline

Start Date

September 30, 2012

Primary Completion Date

January 31, 2016

Study Completion Date

January 31, 2016

Conditions
Kidney Transplant Patients
Interventions
DRUG

A) TEST

"1. Extended Release Tacrolimus (Advagraf®)~ ① Living The day before surgery: 0.2 mg/kg(morning dose) po, qd Morning on the day of surgery: 0.1 mg/kg po, qd After surgery, the capacity is adjusted according to the trough level. clinical significance, electrolyte level.~ ② Cadaveric Before surgery at once : 0.1 mg/kg within 12hours before surgery. After surgery : 0.2mg/kg po. in the morning After that, the capacity is adjusted according to the trough level. clinical significance, electrolyte level.~2. Sirolimus (Rapamune®):~After surgery : 2mg/kg po. within 24hrs after reperfusion. After that, the capacity is adjusted according to the trough level."

DRUG

B) CONTROL

"1. Extended Release Tacrolimus (Advagraf®)~ : Same as above.~2. Mycophenolate mofetil : After surgery : 500mg/kg po. within 24hrs after reperfusion. After that, daily dose: 1000mg bid"

Trial Locations (7)

Unknown

Kyungpook national hospital, Daegu

Ajou Univeristy Medical Center, Suwon

Gangnam Severance hospital, Seoul

Korea University Anam Hospital, Seoul

Seoul National University hospital, Seoul

Ulsan Univ Hospital, Ulsan

120-752

Severance hospital, Seoul

All Listed Sponsors
lead

Yonsei University

OTHER

NCT01680952 - Study to Evaluate the Safety and Efficacy of Extended Release Tacrolimus (Advagraf®) + Sirolimus (Rapamune®), Versus Extended Release Tacrolimus (Advagraf®) + Mycophenolate Mofetil in Kidney Transplant Patients | Biotech Hunter | Biotech Hunter