Efficacy and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Renal Transplant Patients

• Status: Completed
• Trial end date: 2006-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of MYFORMS is to assess efficacy and safety on clinical outcomes of EC-MPS in combination with Cyclosporine microemulsion (CsA-ME) in kidney transplant recipients.

• Phase: Phase 4

Details

• Lead Sponsor: Novartis
• Treatments: Cyclosporine; Cyclosporins; Mycophenolate mofetil; Mycophenolic Acid

Criteria

De Novo-Inclusion criteria

1. Males and females aged 6 years or over.

2. Recipients of cadaveric, living unrelated or living related kidney transplant, treated with CsA-Me, with or without corticosteroids, as primary immunosuppression.

Maintenance-Inclusion criteria

1. Males and females aged 6 years or over.

2. Recipients of first or secondary cadaveric, living related or unrelated donor kidney transplant.

3. Patients currently receiving CsA-ME with or without Mycophenolate mofetil (MMF) or azathioprine, with or without corticosteroids as part of their immunosuppressive regimen for at least 3 months prior to Screening.

4. Patients in a stable condition in terms of graft function (serum creatinine not above 2.3 mg/dL (=204 µmol/L) at screening and at baseline, or not increased by more than 20% at baseline compared to values obtained at screening), no change of immune suppressive regimen due to graft malfunction, and any known clinically significant physical and/or laboratory changes for at least 2 months prior to enrollment.

De Novo and Maintenance-Exclusion Criteria

1. Multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any organ other than kidney.

2. Patients with any known hypersensitivity to MPA, EC-MPS or other components of the formulation (e.g. lactose).

3. Patients with thrombocytopenia (< 75,000/mm3), with an absolute neutrophil count of < 1,500/mm3, and/or leukocytopenia (< 2,500/mm3), and/or hemoglobin < 6 g/dL at Screening or Baseline.

4. Patients with a history of malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin.

Other protocol-defined inclusion/exclusion criteria may apply