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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00154193
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : April 21, 2016
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

September 6, 2005
September 12, 2005
April 21, 2016
June 2004
November 2007   (Final data collection date for primary outcome measure)
  • 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
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Complete list of historical versions of study NCT00154193 on Archive Site
  • Incidence of treated acute rejections
  • Incidence of biopsy-proven acute cellular rejections
  • Patient and Graft survival rates
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Nordic Study in Cardiac and Lung Transplantation: Outcome in Relation to Cyclosporine Microemulsion C2 Levels
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)
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Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Heart and Lung Transplant
Drug: cyclosporine
patients will receive maintenance triple immunosuppression according to local practice consisting of Sandimmun Neoral, MMF/ECMPA or azathioprin and steroids.
Active Comparator: Cyclosporine
Intervention: Drug: cyclosporine
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 Identifier (NCT Number) in Medline.
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November 2007   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
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Study Director: Novartis Novartis
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP