OPERA Study: A Study of Two Dosing Regimens of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients.

PHASE3CompletedINTERVENTIONAL
Enrollment

252

Participants

Timeline

Start Date

May 31, 2006

Primary Completion Date

March 31, 2009

Study Completion Date

March 31, 2009

Conditions
Kidney Transplantation
Interventions
DRUG

mycophenolate mofetil

3 g p.o. in divided doses q12h beginning on the day of renal transplant, Day 0, or the day before, Day -1, and continuing to Week 52, adapted to MPA by AUC on Weeks 2, 6, 12, 26, and 52 to obtain AUC0-12 of 50 milligrams (mg) multiplied by (\*) height (h)/ liter(L).

DRUG

mycophenolate mofetil

2 g p.o. in divided doses q12h beginning on the day of renal transplant, Day 0, or the day before, Day -1, and continuing to Week 52.

DRUG

anti-IL-2R

Induction by IL-2R was administered at Day 0 per standard of care at the site at the investigators discretion.

DRUG

methylprednisolone

500 mg intravenous (i.v.) was administered before or after the transplantation, and 0.5 mg/kg p.o. daily from Day 1 to Day 7.

DRUG

cyclosporine

100-1500 nanograms (ng) per milliliter (mL) from Day 0 to Week 4, 800-1200 ng/mL from Week 4 to Week 12 and 500-800 ng/mL from Week 12 to Week 52

Trial Locations (24)

21079

Dijon

29609

Brest

31054

Toulouse

33076

Bordeaux

34295

Montpellier

35033

Rennes

37044

Tours

38700

La Tronche

44035

Nantes

54511

Vandœuvre-lès-Nancy

59037

Lille

63000

Clermont-Ferrand

67091

Strasbourg

75018

Paris

75475

Paris

75743

Paris

75970

Paris

80480

Salouël

86021

Poitiers

87042

Limoges

92151

Suresnes

94010

Créteil

94275

Le Kremlin-Bicêtre

06002

Nice

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02005562 - OPERA Study: A Study of Two Dosing Regimens of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients. | Biotech Hunter | Biotech Hunter