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: April 20, 2016

Last verified: April 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

September 6, 2005

Last Updated Date

April 20, 2016

Start Date ^ICMJE

June 2004

Primary Completion Date

November 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

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

Enrollment ^ICMJE

190

Completion Date

Not Provided

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

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

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

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