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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2009 by Novartis. Recruitment status was Active, not recruiting

First Received on September 6, 2005. Last Updated on February 6, 2009 History of Changes

Sponsor:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00154193

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	Drug: cyclosporine	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
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.

Resource links provided by NLM:

MedlinePlus related topics: Lung Transplantation

Drug Information available for: Cyclosporine Cyclosporin

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome 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 Outcome Measures:

Incidence of treated acute rejections
Incidence of biopsy-proven acute cellular rejections
Patient and Graft survival rates

Estimated Enrollment:	190
Study Start Date:	June 2004

Eligibility

Ages Eligible for Study:	18 Years and older
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00154193

Locations

Switzerland
Novartis
Basel, Switzerland

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis

More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00154193 History of Changes
Other Study ID Numbers:	COLO400AN001
Study First Received:	September 6, 2005
Last Updated:	February 6, 2009
Health Authority:	Sweden: Swedish National Council on Medical Ethics

Keywords provided by Novartis:

Heart transplant, lung transplant, renal function, cyclosporine C2 Levels

Additional relevant MeSH terms:

Cyclosporins
Cyclosporine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors

Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 12, 2012