Skip to main content
OpenTrials
Completed

NCT Number: NCT02159651

A Survey for Long-term Use of Prograf Capsules in Patient With Interstitial Pneumonia

This study is to evaluate the safety and the efficacy of Prograf in patients with interstitial pneumonia associated with polymyositis / dermatomyositis in acute clinical setting.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Interstitial Pneumonia Associated With Polymyositis/Dermatomyositis Connective Tissue Diseases Dermatomyositis Lung Diseases Lung Diseases, Interstitial Muscular Diseases Musculoskeletal Diseases Myositis Nervous System Diseases Neuromuscular Diseases Polymyositis Respiratory Tract Diseases Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Chugoku, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hospitalized patient
  • Patient diagnosed with Interstitial pneumonia associated with polymyositis/dermatomyositis

Treatment and study plan

Tacrolimus

Drug

oral

Other names: FK506, Prograf

Primary outcomes

  1. Overall survival

    Time frame: Up to three years

Secondary outcomes

  1. Respiratory function test value (%FVC, %DLco)

    Time frame: Up to three years

    Respiratory function is evaluated by % FVC ( percent-predicted forced vital capacity) amd %DLco (diffusion capacity of CO).

  2. Arterial blood gas analysis value (PaO2, AaDO2)

    Time frame: Up to three years

    Arterial blood gas analysis by PaO2 (arterial O2 pressure) and AaDO2 (alveolar-arterial oxygen difference)

  3. Chest CT findings

    Time frame: Up to three years

    CT: computed tomography

  4. Serum KL-6 value (serum SP-D value)

    Time frame: Up to three years

    KL-6 (sialylated carbohydrate antigen KL-6) and SP-D (surfactant protein D) are used as marker of interstitial pneumonia

  5. Patient disposition

    Time frame: Up to three years

    patient disposition includes 1)number of case report forms collected, 2)number of patients analyzed for safety, 3)number of patients analysed for efficacy

  6. Safety assessed by the incidence of adverse events

    Time frame: Up to three years

    Any adverse events which include adverse events leading to death, white blood cell count, erythrocyte sedimentation rate and other abnormal findings from laboratory tests

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

Specified Drug Use-results Survey for Long-term Use of Prograf Capsules in Patient With Interstitial Pneumonia Associated With Polymyositis/Dermatomyositis

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Jun 10, 2014
Registry last updated
Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.