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Clinical Trial: Nordic Study in Cardiac and Lung Transplantation: Outcome in Relation to Cyclosporine Microemulsion C2 Levels
This study is currently recruiting patients.
Verified by Novartis September 2005
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Purpose
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)
| Condition | Intervention | Phase |
|---|---|---|
| Heart and Lung transplant | Procedure: non applicable | Phase IV |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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.
Further Study Details:
Study start: June 2004
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: 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
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00154193
Novartis 41 61 324 1111
Switzerland
Novartis, Basel, Switzerland; Recruiting
Novartis 41 61 324 1111
Study chairs or principal investigators
Novartis, Study Director, Novartis
More Information
Study ID Numbers: COLO400ANO01
Last Updated: September 9, 2005
Record first received: September 6, 2005
ClinicalTrials.gov Identifier: NCT00154193
Health Authority: Sweden: Swedish National Council on Medical Ethics
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 9, 2005
Record first received: September 6, 2005
ClinicalTrials.gov Identifier: NCT00154193
Health Authority: Sweden: Swedish National Council on Medical Ethics
ClinicalTrials.gov processed this record on 2005-09-13
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