Completed

NCT Number: NCT00154193

Nordic Study in Cardiac and Lung Transplantation: Outcome in Relation to 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)

Completed

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Key information

Conditions

Heart and Lung Transplant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis

Basel, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cyclosporine

Drug

patients will receive maintenance triple immunosuppression according to local practice consisting of Sandimmun Neoral, MMF/ECMPA or azathioprin and steroids.

Primary outcomes

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 outcomes

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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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.

Important dates

Study start: 2004
Primary completion: 2007
First posted: Sep 12, 2005
Registry last updated: Feb 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.