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

Novartis

Status and phase: Completed; Phase 4

Conditions: Heart and Lung Transplant

Treatments: Drug: cyclosporine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00154193

COLO400ANO01

Details and patient eligibility

About

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)

Enrollment: 190 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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190 participants in 1 patient group

Cyclosporine

Active Comparator group

Treatment:

Drug: cyclosporine