OPERA Study: A Study of Two Dosing Regimens of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients.
A Randomized Study Comparing the Incidence of Acute Clinical or Subclinical Rejection With Two Dosing Regimens of CellCept in de Novo Renal Transplant Recipients Receiving Induction, Cyclosporine and Brief Steroid Therapy
1 other identifier
interventional
252
1 country
24
Brief Summary
This study will compare the incidence of acute clinical or subclinical rejection between immunosuppression with CellCept at a starting dose of 3mg po daily with therapeutic drug monitoring and standard immunosuppression with CellCept and a fixed dose of 2g po daily, in kidney transplant recipients receiving induction by anti-IRL2, cyclosporine therapy, and early discontinuation of steroids. Patients will be randomized to one of the two treatment arms. The anticipated time on study treatment is 52 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2006
Typical duration for phase_3
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 4, 2013
CompletedFirst Posted
Study publicly available on registry
December 9, 2013
CompletedResults Posted
Study results publicly available
November 11, 2015
CompletedNovember 11, 2015
October 1, 2015
2.8 years
December 4, 2013
June 12, 2014
October 12, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR) Before Week 12 or Acute Subclinical Rejection on Protocol Biopsy at Week 12
BPAR was defined as the presence of clinical signs and kidney biopsy that confirmed the rejection before Week 12. Subclinical acute rejection was defined as an increase of serum creatinine at Week 12 strictly less than 10 percent (%) compared to baseline (BL) values and BPAR of Grade greater than or equal to (≥) 1 according to Banff 1997 classification at Week 12.
Week 12
Secondary Outcomes (11)
Serum Creatinine Values [Micromoles Per Liter (µmol/L)]
Weeks 2, 4, 6, 12, 16, 26, 39, and 52
Creatinine Clearance Values Estimated With the Cockcroft-Gault Equation (Milliliters Per Minute [mL/Min])
Weeks 2, 4, 6, 12, 16, 26, 39, and 52
Creatinine Clearance Values Estimated With the Modification of Diet in Renal Disease (MDRD) Simplified Equation
Weeks 2, 4, 6, 12, 16, 26, 39, and 52
Time to Occurrence of First BPAR Between Day 0 and Week 52 - Percentage of Participants With an Event
Day 0, Weeks 2, 4, 6, 12, 16, 26, 39, and 52
Time to Occurrence of First BPAR Between Day 0 and Week 52
Day 0, Weeks 2, 4, 6, 12, 16, 26, 39, and 52
- +6 more secondary outcomes
Study Arms (2)
Mycophenolate Mofetil, Adapted Dose
EXPERIMENTALParticipants 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, Fixed Dose
ACTIVE COMPARATORParticipants 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.
Interventions
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).
Induction by IL-2R was administered at Day 0 per standard of care at the site at the investigators discretion.
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.
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
Eligibility Criteria
You may qualify if:
- adult patients, aged 18-75 years of age;
- 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.
You may not qualify if:
- patients receiving a second or subsequent kidney transplant, or multi-organ transplant;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Unknown Facility
Bordeaux, 33076, France
Unknown Facility
Brest, 29609, France
Unknown Facility
Clermont-Ferrand, 63000, France
Unknown Facility
Créteil, 94010, France
Unknown Facility
Dijon, 21079, France
Unknown Facility
La Tronche, 38700, France
Unknown Facility
Le Kremlin-Bicêtre, 94275, France
Unknown Facility
Lille, 59037, France
Unknown Facility
Limoges, 87042, France
Unknown Facility
Montpellier, 34295, France
Unknown Facility
Nantes, 44035, France
Unknown Facility
Nice, 06002, France
Unknown Facility
Paris, 75018, France
Unknown Facility
Paris, 75475, France
Unknown Facility
Paris, 75743, France
Unknown Facility
Paris, 75970, France
Unknown Facility
Poitiers, 86021, France
Unknown Facility
Rennes, 35033, France
Unknown Facility
Salouël, 80480, France
Unknown Facility
Strasbourg, 67091, France
Unknown Facility
Suresnes, 92151, France
Unknown Facility
Toulouse, 31054, France
Unknown Facility
Tours, 37044, France
Unknown Facility
Vandœuvre-lès-Nancy, 54511, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffman-LaRoche
Study Officials
- STUDY CHAIR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2013
First Posted
December 9, 2013
Study Start
May 1, 2006
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
November 11, 2015
Results First Posted
November 11, 2015
Record last verified: 2015-10