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

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Novartis

Status and phase

Completed
Phase 4

Conditions

Heart and Lung Transplant

Treatments

Drug: cyclosporine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00154193
COLO400ANO01

Details and patient eligibility

About

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)

Enrollment

190 patients

Sex

All

Ages

18+ years old

Volunteers

No 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/exclusion criteria may applied

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

190 participants in 1 patient group

Cyclosporine
Active Comparator group
Treatment:
Drug: cyclosporine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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