Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in de Novo Kidney Transplant Recipients

• Status: Completed
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Clinical trial for the novo transplant recipients, which aims to assess tolerability and safety and clinical outcomes of EC-MPS in combination with cyclosporine microemulsion (CsA-ME) with or without steroids in a population of kidney transplant recipients.

• Phase: Phase 4

Details

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

Criteria

Inclusion criteria:

• Male and females aged 18 to 75

• Recipients of cadaveric, living unrelated or living related kidney transplant, treated with CsA-ME, with or without corticosteroids, as primary immunosuppression

Exclusion criteria:

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

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

• 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.

Other inclusion/exclusion criteria may apply