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

Tracking Information
First Submitted Date ICMJE	September 6, 2005
First Posted Date ICMJE	September 12, 2005
Last Update Posted Date	April 21, 2016
Study Start Date ICMJE	June 2004
Actual Primary Completion Date	November 2007 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: June 5, 2006)	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
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00154193 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: June 5, 2006)	Incidence of treated acute rejections; Incidence of biopsy-proven acute cellular rejections; Patient and Graft survival rates
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Nordic Study in Cardiac and Lung Transplantation: Outcome in Relation to Cyclosporine Microemulsion C2 Levels
Official Title ICMJE	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.
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 Provided
Study Type ICMJE	Interventional
Study Phase	Phase 4
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
Condition ICMJE	Heart and Lung Transplant
Intervention ICMJE	Drug: cyclosporine; patients will receive maintenance triple immunosuppression according to local practice consisting of Sandimmun Neoral, MMF/ECMPA or azathioprin and steroids.
Study Arms	Active Comparator: Cyclosporine; Intervention: Drug: cyclosporine
Publications *	Iversen M, Nilsson F, Sipponen J, Eiskjaer H, Mared L, Bergan S, Nyström U, Fagertun HE, Solbu D, Simonsen S. Cyclosporine C2 levels have impact on incidence of rejection in de novo lung but not heart transplant recipients: the NOCTURNE study. J Heart Lung Transplant. 2009 Sep;28(9):919-26. doi: 10.1016/j.healun.2009.05.022.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: June 5, 2006)	190
Original Enrollment ICMJE	Not Provided
Study Completion Date	Not Provided
Actual Primary Completion Date	November 2007 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Switzerland
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00154193
Other Study ID Numbers ICMJE	COLO400ANO01
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Novartis ( Novartis Pharmaceuticals )
Study Sponsor ICMJE	Novartis Pharmaceuticals
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Novartis Novartis
PRS Account	Novartis
Verification Date	April 2016
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP