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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00154193
First received: September 6, 2005
Last updated: May 7, 2012
Last verified: May 2012
History of Changes

September 6, 2005
May 7, 2012
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
Not Provided
Complete list of historical versions of study NCT00154193 on ClinicalTrials.gov Archive Site
  • Incidence of treated acute rejections
  • Incidence of biopsy-proven acute cellular rejections
  • Patient and Graft survival rates
Not Provided
Not Provided
Not Provided
 
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)
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
190
Not Provided
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00154193
COLO400ANO01
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Novartis
Novartis
May 2012

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