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RCT of Nintedanib in Fibrotic Sarcoidosis

Study acronym: NINSARC
StatusRecruiting
PhasePhase 4
Started
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Record status
This record was last updated October 23, 2024 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Trial status: Active, Not Recruiting to Recruiting
    • Start date: May 30, 2024 to Jun 30, 2024
    • Site details revised
    v3
  2. Eligibility criteria shortened, about 15 words
    • Secondary endpoints: details revised at 1 of 5 entries
    • Study description expanded, about 1 word
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Sarcoidosis is generally managed with outdoor immune modulatory drugs, most commonly oral steroids and at times drugs like methotrexate or azathioprine as a steroid sparing agent. Around 15-20% of sarcoidosis patient develop fibrosis of the lung parenchyma. The effect of antifibrotics in such patients needs more studies. Nintedanib has been used with good results in patients with fibrosing interstitial lung disease like IPF, SSC- ILD, and other progressive fibrosing ILD. By using nintedanib in fibrotic sarcoidosis it may be possible to limit the functional disability in these patients by slowing the rate of fibrosis and loss of lung function. The use of nintedanib if results in decrease in fibrosis and consequent decline in loss of lung function then it may be a safe and viable option for such patients. The hypothesis of this study is that in patients with fibrotic sarcoidosis on standard of care anti-inflammatory therapy, nintedanib may help in reducing the rate of decline in lung function and progressive fibrosis. The aim is to evaluate the efficacy and safety of nintedanib in subjects with fibrotic sarcoidosis
Trial Details
NCT Number NCT06479603
Lead Sponsor Post Graduate Institute of Medical Education and Research, Chandigarh
Conditions
(from sponsor)		 Sarcoidosis, Pulmonary
Related terms Sarcoidosis, Pulmonary
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov