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Pirfenidone as Bridging Therapy for Lung Transplant in Patients Suffering From Idiopathic Pulmonary Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03258801
Recruitment Status : Withdrawn (Clinical evaluation plan outdated and obsolete due to altered clinical routine)
First Posted : August 23, 2017
Last Update Posted : January 27, 2020
Sponsor:
Collaborator:
Clinical Trials Coordination Centre, Medical University of Vienna
Information provided by (Responsible Party):
Dr. Christopher Lambers, Medical University of Vienna

Brief Summary:

The diagnosis of idiopathic pulmonary fibrosis (IPF) is currently one of the most common diagnoses for patients under evaluation for lung transplantation. In recent years, an absolute increase in prevalence/ incidence of IPF has been observed. There is evidence that patients with IPF on waiting list for lung transplantation might benefit from pirfenidone treatment. Until now, no data are published regarding this important issue in lung transplantation.

Primary objective is to determine whether there is a difference in the duration time of mechanical ventilation (weaning) directly after lung transplantation between patients treated with pirfenidone and patients without pirfenidone treatment. The Secondary objectives are to determine whether there are differences between the pirfenidone treatment group and the control group regarding survival after LUTX, the score on the Saint Georges Respiratory Questionnaire and the decline in forced vital capacity (FVC%) In this Investigator initiated, non- interventional single center study , patients on the waiting list for transplant pirfenidone treatment receive oral pirfenidone at the standard dose of 2403 mg per day. The treatment duration will range from 6 to 12 months. A control group will be used to correlate the outcome-parameters for a descriptive comparison. The control group includes patients with IPF on the waiting list who were on another IPF specific (or no) treatment for IPF The Study Population are Patients aged between 40-70 years who are admitted to the lung transplantation department and fulfill the international criteria for idiopathic pulmonary fibrosis ( existence of a usual interstitial pneumonia (UIP) pattern in the high-resolution computed tomography (HRCT) is necessary).

Variables: Duration of mechanical ventilation after LUTX (hours), Forced Vital capacity relative to reference value at baseline (FVC0%), Forced Vital capacity relative to reference value after 6 months (FVC6%),Forced Vital capacity relative to reference value after 12 months (FVC12%) Study Size: 30 patients in the Pirfenidone group, 20 patients in the control group.

For the primary Endpoint, the mean, standard deviation, median, minimum and maximum of the weaning time of patients who received a pirfenidone treatment, as well as of patients from the control group will be computed and presented in a table. Additionally, a Kaplan-Meier curve will be estimated and plotted alongside the respective 95% CI calculated using the method of Brookmeyer and Crowley. Furthermore, a stepwise linear regression using forward selection and Age, RBMI, FVC0%, (FVC6%-FVC0%), TLC, FEV1% and ECMO, as well as the pirfenidone treatment as predictors will be computed. The null hypothesis is that the pirfenidone treatment has no influence on the weaning time. The according model coefficient estimate and standard error will be used to test the null hypothesis using a t-test at significance level α=0.05.

For the secondary endpoints, the mean, standard deviation, median, minimum and maximum of patients who received a pirfenidone treatment, as well as of patients from the control group will be computed and presented in a tableStepwise Cox Regression using forward selection and Age, RBMI, FVC0%, (FVC6%-FVC0%) and ECMO, as well as the pirfenidone treatment as predictors will be computed in order to compare the treatment and the control group a . If p-values are calculated for the secondary endpoint analysis, they serve only descriptive purposes. Therefore no multiple testing corrections are applied.


Condition or disease
Idiopathic Pulmonary Fibrosis Lung Transplant; Complications

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pirfenidone as Bridging Therapy for Lung Transplant in Patients Suffering From Idiopathic Pulmonary Fibrosis
Actual Study Start Date : October 29, 2018
Actual Primary Completion Date : December 2, 2019
Actual Study Completion Date : December 2, 2019


Group/Cohort
Pirfenidone
Patients who are admitted to the lung transplantation department and fulfill the international criteria for idiopathic pulmonary fibrosis and are treated with Pirfenidone as bridging therapy.
Control
Patients who are admitted to the lung transplantation department and fulfill the international criteria for idiopathic pulmonary fibrosis and are not treated with Pirfenidone.



Primary Outcome Measures :
  1. Duration time of mechanical ventilation (weaning) directly after lung transplantation [ Time Frame: First two weeks after lung transplantation ]
    Duration of mechanical ventilation after LUTX measured in days


Secondary Outcome Measures :
  1. Days of survival after LUTX [ Time Frame: First 90 days after LUTX ]
    Days of survival after LUTX measured in days

  2. decline in forced vital capacity (FVC%) from baseline to 6 months [ Time Frame: from baseline to 6 months ]
    decline in forced vital capacity (FVC%) from baseline to 6 months

  3. decline in forced vital capacity (FVC%) from baseline to 12 months [ Time Frame: from baseline to 12 months ]
    decline in forced vital capacity (FVC%) from baseline to 12 months

  4. decline in forced vital capacity (FVC%) from 6 months to 12 months [ Time Frame: from 6 months to 12 months ]
    decline in forced vital capacity (FVC%) from 6 months to 12 months



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients who are admitted to the lung transplantation department and fulfill the international criteria for idiopathic pulmonary fibrosis will be evaluated (existence of a usual interstitial pneumonia (UIP) pattern in the high-resolution computed tomography (HRCT) is necessary).

The assignment of a patient to a particular therapeutic strategy remains in the sole responsibility of the treating physician and must not be dictated by this study-specific observation- and evaluation plan

Criteria

Inclusion Criteria:

For Pirfenidone Group

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study

  • mild to moderate idiopathic pulmonary fibrosis (IPF).
  • Current or intended treatment with Pirfenidone
  • Diagnosis of Interstitial Lung disease
  • Evaluation for Lung Transplantation
  • Age 40-70

For Control Group

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study

  • mild to moderate idiopathic pulmonary fibrosis (IPF).
  • Diagnosis of Interstitial Lung disease
  • Evaluation for Lung Transplantation
  • Age 40-70

Exclusion Criteria:

For Pirfenidone Group

  • Other lung diseases (such as cystic fibrosis, COPD)
  • Infection with Hepatitis C,
  • Liver cirrhosis CHILD C
  • Coronary heart disease (3VD)

For Control Group

  • Other lung diseases (such as cystic fibrosis, COPD)
  • Infection with Hepatitis C,
  • Liver cirrhosis CHILD C
  • Coronary heart disease (3VD)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03258801


Locations
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Austria
Medical University of Vienna, Department of Surgery
Vienna, Austria, 1090
Sponsors and Collaborators
Dr. Christopher Lambers
Clinical Trials Coordination Centre, Medical University of Vienna
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Responsible Party: Dr. Christopher Lambers, Ass. Prof., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT03258801    
Other Study ID Numbers: NIS-ML-29952
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial