Nordic Study in Cardiac and Lung Transplantation: Outcome in Relation to 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...
Brief Summary
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.”
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)
- Study Type: Interventional
- Study Design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention(s) in this Clinical Trial
- Drug: cyclosporine
Outcome Measures for this Clinical Trial
Primary Measures
- 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 Measures
- Incidence of treated acute rejections
- Incidence of biopsy-proven acute cellular rejections
- Patient and Graft survival rates
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Clinical Trial Investigator Information
Lead Investigator: Novartis Pharmaceuticals Industry
Overall Clinical Trial Officials and Contacts
Novartis Study Director Novartis
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00154193
Study ID Number: COLO400AN001
ClinicalTrials.gov Identifier: NCT00154193
Health Authority: Sweden: Swedish National Council on Medical Ethics
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00154193
