Phase 3
Completed N=252
OPERA Study: A Study of Two Dosing Regimens of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients.
Source: ClinicalTrials.gov NCT02005562 ↗Enrolled (actual)
252
Serious AEs
79.4%
Results posted
Nov 2015
Primary outcomePrimary: Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR) Before Week 12 or Acute Subclinical Rejection on Protocol Biopsy at Week 12 — 24.2; 19.8 percentage of participants — p=0.479
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR) Before Week 12 or Acute Subclinical Rejection on Protocol Biopsy at Week 12 |
24.2; 19.8 | 0.479 |
| SECONDARY Serum Creatinine Values [Micromoles Per Liter (µmol/L)] |
202.41; 201.31; 168.92; 174.86; 155.74; 158.96 | 0.6736 |
| SECONDARY Creatinine Clearance Values Estimated With the Cockcroft-Gault Equation (Milliliters Per Minute [mL/Min]) |
46.68; 45.26; 51.03; 46.73; 53.66; 49.77 | 0.2172 |
| SECONDARY Creatinine Clearance Values Estimated With the Modification of Diet in Renal Disease (MDRD) Simplified Equation |
40.61; 39.60; 45.02; 41.31; 48.12; 44.69 | 0.4770 |
| SECONDARY Time to Occurrence of First BPAR Between Day 0 and Week 52 - Percentage of Participants With an Event |
24.6; 14.9 | — |
| SECONDARY Time to Occurrence of First BPAR Between Day 0 and Week 52 |
NA; NA | 0.0764 |
| SECONDARY Percentage of Participants With at Least One BPAR at Week 12 and Week 52 |
14.1; 10.0; 9.1; 10.0 | 0.418 |
| SECONDARY Graft Histology - Percentage of Participants With at Least One Borderline Lesion at Week 12 and Week 52 |
7.9; 12.4; 6.4; 5.0 | 0.245 |
| SECONDARY Graft Histology - Percentage of Participants With at Least One Chronic Graft Nephropathy at Week 12 and Week 52 |
20.6; 17.4; 32.5; 34.7 | 0.512 |
| SECONDARY Graft Loss - Percentage of Participants With an Event |
5.6; 5.0 | — |
| SECONDARY Time to Graft Loss |
NA; NA | 0.860 |
| SECONDARY Participant Survival |
98.4; 98.3 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02005562). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.