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...
Date First Received: September 6, 2005
Last Updated: February 6, 2009
Verified by: Novartis, February 2009
Clinical Trial Phase: Phase 4 | Start Date: June 2004
Overall Status: Active, not recruiting
Estimated Enrollment: 190
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.”
Condition Keyword(s):
Intervention(s):
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: Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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 Sponsor Information
Lead Sponsor: Novartis Pharmaceuticals
Overall Clinical Trial Officials and Contacts
Novartis Study Director Novartis
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
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
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
