Nordic Study in Cardiac and Lung Transplantation: Outcome in Relation to Cyclosporine Microemulsion C2 Levels

A 12-month Study to Investigate the Correlations Between Cyclosporine Microemulsion C2 Levels (High, Medium and Low) and AUC0-4 With Regard to Outcome in de Novo Heart and Lung Transplantation - Identification of Target Cyclosporine Microemulsion C2 Levels.

The main purpose of this study is to identify cyclosporine C2 levels during 12 months treatment , while cyclosporine microemulsion dosages are adjusted based on C0 cyclosporine blood samples, and retrospectively correlate C2 levels to outcome (renal function and incidence of acute rejections)

Inclusion Criteria:

• Patients receiving a first heart or bilateral or single lung transplant
• Patients for whom a triple maintenance immunosuppressive therapy consisting of cyclosporine microemulsion, steroids and mycophenolate mofetil (MMF)/ enteric-coated mycophenolate sodium (EC-MPS ,(or azathioprine) is indicated.

Exclusion Criteria:

• Multi-organ transplants or previously transplanted organs
• Patients with the need of more than two cyclosporine microemulsion dosages per day

Other protocol-defined inclusion/exclusion criteria may applied