Tacrolimus/Everolimus Versus Tacrolimus/Enteric-Coated Mycophenolate Sodium

PHASE3CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

November 30, 2012

Primary Completion Date

December 31, 2014

Study Completion Date

December 31, 2014

Conditions
Transplant; Failure, Kidney
Interventions
DRUG

Tacrolimus

Tacrolimus dosing (rTd) is planned, 0.1 mg/kg PO BID - beginning when serum Cr decreases to a level of \<4 mg/dl (i.e., acceptable renal transplant function) postoperatively. Target tacrolimus trough levels during the first year post-transplant and thereafter will be 5-8 ng/ml.

DRUG

Everolimus

Everolimus initiated at 0.75 PO BID and will be adjusted in order to achieve target everolimus trough levels of 3-8 ng/ml.

DRUG

Enteric Coated Mycophenolate Sodium (EC-MPS)

EC-MPS 720 mg PO BID - beginning on 1st postoperative day.

DRUG

Corticosteroids

Corticosteroids will be given as per our center protocol, i.e., a bolus of 500 mg of Methylprednisolone intravenously at surgery and daily x2, followed by 1.0 mg/kg, then 0.5 mg/kg orally until weaned off completely by 7-10 days postoperatively - the plan is for corticosteroids to be discontinued by 7-10 days postoperatively in both groups.

Trial Locations (1)

33136

University of Miami, Miami

All Listed Sponsors
lead

Gaetano Ciancio

OTHER

NCT01680861 - Tacrolimus/Everolimus Versus Tacrolimus/Enteric-Coated Mycophenolate Sodium | Biotech Hunter | Biotech Hunter