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

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Cyclosporine; Cyclosporins; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Mycophenolate mofetil; Mycophenolic Acid; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

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.