Clinical trial NCT02005562: OPERA Study: A Study of Two Dosing Regimens of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kidney Transplantation
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-12-09
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR) Before Week 12 or Acute Subclinical Rejection on Protocol Biopsy at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Serum Creatinine Values [Micromoles Per Liter (µmol/L)]
timeFrame: Weeks 2, 4, 6, 12, 16, 26, 39, and 52
measure: Creatinine Clearance Values Estimated With the Cockcroft-Gault Equation (Milliliters Per Minute [mL/Min])
timeFrame: Weeks 2, 4, 6, 12, 16, 26, 39, and 52
measure: Creatinine Clearance Values Estimated With the Modification of Diet in Renal Disease (MDRD) Simplified Equation
timeFrame: Weeks 2, 4, 6, 12, 16, 26, 39, and 52
measure: Time to Occurrence of First BPAR Between Day 0 and Week 52 - Percentage of Participants With an Event
timeFrame: Day 0, Weeks 2, 4, 6, 12, 16, 26, 39, and 52
measure: Time to Occurrence of First BPAR Between Day 0 and Week 52
timeFrame: Day 0, Weeks 2, 4, 6, 12, 16, 26, 39, and 52
measure: Percentage of Participants With at Least One BPAR at Week 12 and Week 52
timeFrame: Weeks 12 and 52
measure: Graft Histology - Percentage of Participants With at Least One Borderline Lesion at Week 12 and Week 52
timeFrame: Weeks 12 and 52
measure: Graft Histology - Percentage of Participants With at Least One Chronic Graft Nephropathy at Week 12 and Week 52
timeFrame: Weeks 12 and 52
measure: Graft Loss - Percentage of Participants With an Event
timeFrame: Day 0, Weeks 2, 4, 6, 12, 16, 26, 39, and 52
measure: Time to Graft Loss
timeFrame: Day 0, Weeks 2, 4, 6, 12, 16, 26, 39, and 52
measure: Participant Survival
timeFrame: Day 0, Weeks 2, 4, 6, 12, 16, 26, 39, and 52
Other outcomes:
Locations:
city: Bordeaux
country: France
city: Brest
country: France
city: Clermont-ferrand
country: France
city: Creteil
country: France
city: Dijon
country: France
city: La Tronche
country: France
city: Le Kremlin-bicetre
country: France
city: Lille
country: France
city: Limoges
country: France
city: Montpellier
country: France
city: Nantes
country: France
city: Nice
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Poitiers
country: France
city: Rennes
country: France
city: Salouel
country: France
city: Strasbourg
country: France
city: Suresnes
country: France
city: Toulouse
country: France
city: Tours
country: France
city: Vandoeuvre-les-nancy
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References: