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Tacrolimus Versus Cyclosporine for Immunosuppression After Lung Transplantation

NCT01429844 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 274

Last updated 2011-09-07

No results posted yet for this study

Summary

The purpose of the study is to compare efficacy and safety of two different immunosuppressive regimens for prevention of bronchiolitis obliterans syndrome (BOS) (chronic lung allograft rejection)after lung transplantation: tacrolimus versus cyclosporine, both in combination with mycophenolate mofetil and steroids. The study was powered to detect a 15% reduction in BOS in tacrolimus treated patients.

Study design: open-label, randomized, comparative, multi-center, investigator driven

Conditions

  • Bronchiolitis Obliterans
  • Immunosuppression

Interventions

DRUG

Tacrolimus

Tacrolimus therapy was started immediately after transplantation with a continuous intravenous infusion of 0.01-0.03 mg/kg/d. After extubation, the mode of delivery was switched to oral administration (b.i.d.) with doses of 0.05-0.3 mg/kg/d. Tacrolimus doses were adjusted to trough levels. Target C0 (trough) levels were 10-15 ng/ml for the first 3 months after transplantation and 8-12 ng/ml thereafter with dose adjustments according to patient outcome.

DRUG

Cyclosporine

Cyclosporine therapy was started immediately after transplantation with a continuous intravenous infusion of 1-3 mg/kg/d. After extubation the mode of delivery was switched to oral administration (b.i.d. or t.i.d.) with doses of 4-18 mg/kg/d. Cyclosporine doses were adjusted to C0 or C2 levels according to local practice. Target trough levels were 200 - 300 ng/ml for the first 3 months after transplantation and 150 - 200 ng/ml thereafter.

Sponsors & Collaborators

  • Universitätsklinikum Hamburg-Eppendorf

    lead OTHER

Principal Investigators

  • Hermann Reichenspurner, MD, PhD · Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany

  • Allan Glanville, MD, PhD · St Vincent's Hospital - Sydney, Australia

  • Hendrik Treede, MD · Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
66 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-01-31
Primary Completion
2007-10-31
Completion
2010-08-31

Countries

  • Australia
  • Austria
  • Belgium
  • Germany
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01429844 on ClinicalTrials.gov