Tokyo, Aug. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062524) titled 'Antifibrotic therapy for Interstitial Lung disease: a Prospective Study in Koshinetsu region' on Aug. 15.
Study Type:
Observational
Primary Sponsor:
Institute - Shinshu University
Condition:
Condition - Interstitialu lung disease
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To identify the prescription proportions of various antifibrotic therapies and patient clinical characteristics in a multicenter real-world database of patients with interstitial lung disease (ILD). Furthermore, this study aims to clarify the differences in treatment status between elderly and younger patients, and to evaluate the impact of baseline nutritional status, skeletal muscle mass, and longitudinal changes in nutritional indices on the long-term prognosis and clinical events of ILD.
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - 1. Patients diagnosed with interstitial lung disease (ILD), such as idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF), at the participating institutions.
2. Patients who are scheduled to initiate or have already initiated a new or additional antifibrotic drug (e.g., nintedanib, pirfenidone, nerandomilast).
3. Patients aged 20 years or older at the time of registration.
Key exclusion criteria - 1. Patients who decline to participate in the study via the opt-out public notification.
2. Patients otherwise judged inappropriate for enrollment by the principal investigator or sub-investigators.
Target Size - 200
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2026 Year 07 Month 15 Day
Date of IRB - 2026 Year 08 Month 05 Day
Anticipated trial start date - 2026 Year 07 Month 15 Day
Last follow-up date - 2033 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070885
Disclaimer: Curated by HT Syndication.