Calcineurin Inhibitor (CNI) Versus Steroid Cessation in Renal Transplantation

PHASE4UnknownINTERVENTIONAL
Enrollment

152

Participants

Timeline

Start Date

October 31, 2008

Primary Completion Date

April 30, 2010

Study Completion Date

April 30, 2015

Conditions
Renal Transplantation
Interventions
DRUG

cyclosporine

"Cyclosporine (Group 1):~basiliximab dose: 1x20 mg IV on Day 0 and 1x20 mg IV on Day 4~Cyclosporine: 8 mg/kg PO given before surgery, followed by 2x4 mg/kg/d. C-0h levels: month 1: 150-250 ng/ml; month 2: 100-200 ng/ml; month 3: withdrawal steroids: 100-150 ng/ml.~C-2h levels: month 1: 900-1100 ng/ml; month 2: 800-1000 ng/ml; month 3: withdrawal steroids: maintain level of 750 ng/ml~Enteric-coated mycophenolate(MPA):720mg PO pre-operatively followed by 1.44 g/day.~Steroids: pre-operatively: 250mg methylprednisolone IV; day 1:125mg IV.~Methylprednisolone:day 2-30:PO 12mg/d; day 31-60:tapered to 8mg/d ,day 61-90 :4mg/d; Month 3:stop"

DRUG

Everolimus

"Everolimus (Group 2):~Basiliximab dose: idem as in group 1~Cyclosporine: first three months idem group 1; month 3: decreased dose by 50%, simultaneously initiate everolimus at a starting dose of 0.75 mg bid.~Once the everolimus blood levels range 6 - 12 ng/ml, cyclosporine will be stopped.~Enteric-coated mycophenolate (MPA) dosing idem as group 1.~Everolimus starting dose: 0.75 mg bid, trough levels: 6-12 ng/ml.~Steroid dosing: idem group 1, but maintained at 4 mg methylprednisolone after day 60."

Trial Locations (5)

1070

RECRUITING

Erasme University Hospital, Brussels

1090

RECRUITING

University Hospital Brussels, Brussels

2650

RECRUITING

University Hospital Antwerp, Edegem

4000

RECRUITING

University Hospital of Liege, Liège

9000

RECRUITING

University Hospital, Ghent, Ghent

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis Pharmaceuticals

INDUSTRY

collaborator

Erasme University Hospital

OTHER

collaborator

University Hospital, Ghent

OTHER

collaborator

University of Liege

OTHER

collaborator

Universitair Ziekenhuis Brussel

OTHER

lead

University Hospital, Antwerp

OTHER