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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00154193

Enrollment

190

Registered

2005-09-12

Start date

2004-06-30

Completion date

Unknown

Last updated

2020-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart and Lung Transplant

Keywords

Heart transplant, lung transplant, renal function, cyclosporine 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)

Interventions

DRUGcyclosporine

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Patient and Graft survival rates	—
Incidence of treated acute rejections	—
Incidence of biopsy-proven acute cellular rejections	—

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026