OPERA Study: A Study of Two Dosing Regimens of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients.
NCT ID: NCT02005562
Last Updated: 2015-11-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
252 participants
INTERVENTIONAL
2006-05-31
2009-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Mycophenolate Mofetil, Adapted Dose
Participants received 3 grams (g) mycophenolate mofetil (MMF) tablets per os (p.o.) in divided doses (every 12 hours \[q12h\]) adapted to mycophenolic acid (MPA) by area under the curve (AUC) beginning on the day of renal transplant, Day 0, or the day before, Day -1, and continuing through Week 52. In addition, induction by interleukin-2R (IL-2R) was administered at Day 0 per standard of care at the site at the investigator's discretion. At 72 hours post-transplantation, participants received cyclosporine 100-1500 nanograms (ng) per (/) milliliter (mL) from Day 0 to (-) Week 4, 800-1200 ng/mL from Week 4 - Week 12 and 500-800 ng/mL from Week 12 - Week 52. Solumedrol 500 mg intravenously (i.v.) was administered before or after the transplantation, and 0.5 milligrams (mg) per kilogram (kg) p.o. daily from Day 1 - Day 7.
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).
anti-IL-2R
Induction by IL-2R was administered at Day 0 per standard of care at the site at the investigators discretion.
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.
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
Mycophenolate Mofetil, Fixed Dose
Participants received 2 g MMF tablets p.o. in divided doses q12h beginning on the day of renal transplant, Day 0, or the day before, Day -1, and continuing through Week 52. In addition, induction by IL-2R was administered at Day 0 per standard of care at the site at the investigators discretion. At 72 hours post-transplantation, participants received cyclosporine 100-1500 ng/mL from Day 0 - Week 4, 800-1200 ng/mL from Week 4 - Week 12 and 500-800 ng/mL from Week 12 - Week 52. Solumedrol 500 mg i.v. was administered before or after the transplantation, and 0.5 mg/kg p.o. daily from Day 1 - Day 7.
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.
anti-IL-2R
Induction by IL-2R was administered at Day 0 per standard of care at the site at the investigators discretion.
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.
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
Interventions
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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).
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.
anti-IL-2R
Induction by IL-2R was administered at Day 0 per standard of care at the site at the investigators discretion.
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.
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* in receipt of first donor kidney;
* eligible to receive immunosuppressive treatment comprising IRL2, CellCept, cyclosporine and steroids;
* eligible to receive oral treatment from the first day post-transplantation.
Exclusion Criteria
* history of malignancy in the last 5 years (except successfully treated squamous cell or basal cell cancer and cervical cancer in situ);
* patients with active hepatitis B and/or hepatitis C, or HIV infection.
18 Years
75 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_CHAIR
Hoffmann-La Roche
Locations
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Bordeaux, , France
Brest, , France
Clermont-Ferrand, , France
Créteil, , France
Dijon, , France
La Tronche, , France
Le Kremlin-Bicêtre, , France
Lille, , France
Limoges, , France
Montpellier, , France
Nantes, , France
Nice, , France
Paris, , France
Paris, , France
Paris, , France
Paris, , France
Poitiers, , France
Rennes, , France
Salouël, , France
Strasbourg, , France
Suresnes, , France
Toulouse, , France
Tours, , France
Vandœuvre-lès-Nancy, , France
Countries
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Other Identifiers
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ML19912
Identifier Type: -
Identifier Source: org_study_id
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