Randomized Phase 2 study of Nintedanib and Pirfenidone versus Nintedanib following a clinically meaningful decline in forced vital capacity in patients with idiopathic pulmonary fibrosis administering pirfenidone

Randomized Phase 2 study of Nintedanib and Pirfenidone versus Nintedanib following a clinically meaningful decline in forced vital capacity in patients with idiopathic pulmonary fibrosis administering pirfenidone - Randomized Phase 2 study of Nintedanib and Pirfenidone versus Nintedanib following a clinically meaningful decline in forced vital capacity in patients with idiopathic pulmonary fibrosis administering pirfenidone

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000019436

Enrollment

Registered

2015-10-21

Start date

2015-10-16

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

idiopathic pulmonary fibrosis

Interventions

Nintedanib+pirfenidone group

Nintedanib 150mg twice daily Pirfenidone 600-1800mg/day Nintedanib group

Nintedanib 150mg twice daily

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Idiopathic pulmonary fibrosis 2) >= 40 years old 3) Pirfenidone (600-1800mg/day) was administered for more than 3 months 4) patients who experience a >=5% decline in forced vital capacity within the recent 6 months 5) Adequate organ functions 6) Survival >= 6 months is expected 7) Written informed consent

Exclusion criteria

Exclusion criteria: 1) AST/ALT/T-bil >= reference value * 2.5 2) The patients who has already received corticosteroid (<=15mg/day), immuno-supressant, NAC, pulmonary vasodilators, and other treatment for IPF 3) Active infection 4) Malignant tumor 5) Other severe complication 6) pregnant or lactating woman 7) severe drug allergy 8) It is determined that it is not suited

Design outcomes

Primary

Measure	Time frame
The ratio of patients who experienced >5% absolute decline in %FVC or death during the first 6-months	—

Secondary

Measure	Time frame
1) The ratio of patients who experienced >10% absolute decline in %FVC or death during the first 6-months 2) Decline of FVC at 1,3,6,9,12 months 3) The occurence rate of acute excerbation 4) Change in %FVC and %DLco 5) 6 minutes walk test 6) Serum biomarker 7) HRCT findings 8) Toxicity 9) Progression free survival 10) Survival	—

Countries

Japan

Contacts

Public ContactSatoshi Ikeda

Kanagawa Cardiovascular and Respiratory Center Department of Respiratory Medicine

isatoshi0112@gmail.com0457019581

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026