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NCT03562416
Continuation of Nintedanib After Single Lung Transplantation in IPF Subjects
Phase 2 trial testing Nintedanib in Idiopathic Pulmonary Fibrosis in 1 participant. Terminated before completion.
21 December 2021
Quick facts
| Lead sponsor | Temple University |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 1 |
| Start date | 5 July 2019 |
| Primary completion | 21 December 2021 |
| Estimated completion | 21 December 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Nintedanib (NINTEDANIB) — full drug profile →
- Placebo Oral Tablet — full drug profile →
Conditions studied
- Idiopathic Pulmonary Fibrosis — all drugs for Idiopathic Pulmonary Fibrosis →
- Lung Transplant; Complications — all drugs for Lung Transplant; Complications →
Sponsor
Temple University
Who can join
Adults 35 to 70, any sex, with Idiopathic Pulmonary Fibrosis or Lung Transplant; Complications. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of this study is to assess the utility of nintedanib therapy in addition to usual transplant care in single lung transplant recipients with idiopathic pulmonary fibrosis (IPF). The investigators hypothesize that in IPF subjects who undergo single lung transplantation the administration of nintedanib 150 mg twice daily in addition to usual transplant care will result in better preservation of lung function at 24 months.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Antifibrotic drugs in lung transplantation and chronic lung allograft dysfunction: a review.
Bos S, De Sadeleer LJ, Vanstapel A, Beeckmans H, et al · · 2021 · cited 14× · PMID 34415849 · DOI 10.1183/16000617.0050-2021 -
Nintedanib in progressive bronchiolitis obliterans syndrome (BOS) grade 0p-1-2 in lung transplant recipients (INFINITIx-BOS): protocol of a French multicenter randomized controlled trial.
Brugière O, Hirschi S, Reynaud-Gaubert M, Bunel V, et al · · 2026 · PMID 41964069 · DOI 10.1186/s13063-025-09314-7
Verify or expand the search:
- PubMed search for NCT03562416
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Idiopathic Pulmonary Fibrosis
Currently open trials in the same condition.
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Other Temple University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03562416 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Temple University
- Last refreshed: 7 April 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03562416.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing