Nordic Study in Cardiac and Lung Transplantation: Outcome in Relation to Cyclosporine Microemulsion C2 Levels
- Registration Number
- NCT00154193
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 190
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cyclosporine cyclosporine -
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method Incidence of treated acute rejections Patient and Graft survival rates Incidence of biopsy-proven acute cellular rejections
Trial Locations
- Locations (1)
Novartis
🇨🇭Basel, Switzerland