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

Roche

Status and phase: Completed; Phase 3

Conditions: Kidney Transplantation

Treatments: Drug: methylprednisolone; Drug: mycophenolate mofetil; Drug: cyclosporine; Drug: anti-IL-2R

Study type: Interventional

Funder types: Industry

Identifiers

NCT02005562

ML19912

Details and patient eligibility

About

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.

Enrollment: 252 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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252 participants in 2 patient groups

Mycophenolate Mofetil, Adapted Dose

Experimental group

Description:

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.

Treatment:

Drug: anti-IL-2R

Drug: cyclosporine

Drug: mycophenolate mofetil

Drug: mycophenolate mofetil

Drug: methylprednisolone

Mycophenolate Mofetil, Fixed Dose

Active Comparator group

Description:

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.

Treatment:

Drug: anti-IL-2R

Drug: cyclosporine

Drug: mycophenolate mofetil

Drug: mycophenolate mofetil

Drug: methylprednisolone