Effect of Everolimus on the Pharmacokinetics of Tacrolimus in Renal Transplant Patients

PHASE4CompletedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

April 30, 2014

Primary Completion Date

January 15, 2019

Study Completion Date

January 15, 2019

Conditions
Drug Interaction Potentiation
Interventions
DRUG

Everolimus

Everolimus: 1 mg orally every 12 hours from post-operation day 1 to achieve trough concentrations of 3-8 ng/mL

DRUG

Mycophenolate mofetil

Mycophenolate mofetil: 10-15 mg/kg orally every 12 hours from post-operation day 1 (decrease 50% dose if white blood cell \< 4000/mcL)

DRUG

Tacrolimus

Tacrolimus: 0.05-0.075 mg/kg orally every 12 hours from post-operation day 1 to achieve trough concentrations of 8-12 ng/mL

DRUG

Methylprednisolone

Methylprednisolone: 50 mg iv every 6 hours on post-operation day 1, 40 mg iv every 6 hours on post-operation day 2, 30 mg iv every 6 hours on post-operation day 3, 20 mg iv every 6 hours on post-operation day 4, 20 mg iv every 8 hours on post-operation day 5, 20 mg iv every 12 hours on post-operation day 6, 20 mg iv on post-operation day 7

DRUG

Prednisolone

Prednisolone: 20 mg orally once a day from post-operation day 8 to post-operation week 4, then titrated gradually

Trial Locations (1)

Unknown

National Taiwan University Hospital, Taipei

All Listed Sponsors
lead

National Taiwan University Hospital

OTHER

NCT02077556 - Effect of Everolimus on the Pharmacokinetics of Tacrolimus in Renal Transplant Patients | Biotech Hunter | Biotech Hunter