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

Novartis Pharmaceuticals190 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

190

Conditions

Heart and Lung Transplant

Interventions

cyclosporineDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Novartis

Basel, Switzerland

Outcomes

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

Data from ClinicalTrials.gov

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