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

Heart and Lung Transplant Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00154193
• Other study ID #: COLO400ANO01
• Status: Completed
• Phase: Phase 4
• Start date: June 2004

Study information

• Verified date: April 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart and Lung Transplant

Intervention

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

Locations

Country	Name	City	State
Switzerland	Novartis	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The average number of treated acute cardiac and lung graft rejection per patient during the first 12 months post transplant
Primary	The measured Glomerular Filtration Rate (GFR) at 3 and 12 months post-transplant
Secondary	Incidence of treated acute rejections
Secondary	Incidence of biopsy-proven acute cellular rejections
Secondary	Patient and Graft survival rates