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

Condition(s) targeted: Heart and Lung Transplant

Intervention: cyclosporine (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis, Study Director, Affiliation: Novartis

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)

Official title: 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.

Study design: Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Primary outcome:

The average number of treated acute cardiac and lung graft rejection per patient during the first 12 months post transplant

The measured Glomerular Filtration Rate (GFR) at 3 and 12 months post-transplant

Secondary outcome:

Incidence of treated acute rejections

Incidence of biopsy-proven acute cellular rejections

Patient and Graft survival rates

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Novartis, Basel, Switzerland

Starting date: June 2004
Last updated: January 25, 2008