Zinc and Nicotinamide Riboside for Idiopathic Pulmonary Fibrosis

Korábbi kezelés

• Any acute illness or febrile event that has not resolved at least 14 days prior to either screening or the first study visit
• Participation in a clinical study involving administration of other investigational drugs in the 30 days prior to screening
• Likelihood of lung transplantation in the first 12 weeks of the study
• Use of other IPF-directed therapies beside SOC including but not limited to endothelium receptor antagonists, interferon gamma-1b, N-acetylcysteine
• Initiation of pirfenidone or nintedanib less than 60 days prior to screening
• Current therapy or treatment within 60 days prior to screening of any cytotoxic or immunosuppressive medications, cytokine modulating therapies within 4 weeks of the screening visit
• Chronic use of any restricted medications known to have significant interactions with zinc supplementation (see Section 6.5)
• Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina
• Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
• Prior allogeneic stem cell or solid organ transplantation

Más betegség

• Evidence of secondary etiologies of ILD (signs/symptoms of connective tissue disease, including ANA titer > 1:80, history of exposures related to hypersensitivity pneumonitis, history of drug related pulmonary toxicity, occupational exposures)
• Evidence of comorbid pulmonary pathology including but not limited to asthma, tuberculosis, sarcoidosis, chronic infections
• Any condition that in the opinion of the investigators would confound the ability to interpret data from the study
• Any comorbid condition that is likely to result in death within the next year
• History of active malignancy in the last 5 years, with the exception of carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer

Laborértékek

• Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the participant at high risk from treatment complications

Egyéb

• FVC < 40% of predicted, DLCO < 30% of predicted, FEV1/FVC with Z-score < -1.645 or confidence interval <1.0 within 3 months of screening. If Z-scores or confidence intervals are not available, then FEV1/FVC < the lower limit of normal will be used as exclusion
• Use of tobacco-containing products within the last 3 months and/or unwillingness to abstain from use for the duration of the study
• Inability to obtain reproducible, high-quality pulmonary function tests
• Chronic prednisone usage at a dose \&amp;gt; 10 mg daily
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Be under active treatment for IPF by a local pulmonologist
• Age \&amp;gt; 50 years
• Confident diagnosis of IPF per the latest ATS/ERS/JRS/ALAT Clinical Practice Guideline on Diagnosis of IPF10
  • Subjects must have a high-resolution computed tomography (HRCT) completed in the 6 months as part of their standard of care prior to informed consent
  • Subjects must have HRCT pattern of definite or probable UIP
  • Subjects without HRCT pattern of definite or probable UIP must have surgical lung biopsy as part of their standard of care showing histopathology consistent with UIP
  • Extent of fibrotic changes must be greater than the extent of emphysema on HRCT
• Able to take oral medication and willing to adhere to the study treatment regimen
• Ability to utilize CS-Link, Zoom, or Doximity video conferencing for virtual study visits
• Ability to complete PFT and 6 minute walk distance test every 12 weeks per standard of care under the order of a local treating pulmonologist
• Ability to complete HRCT at baseline and 24 weeks per standard of care under the order of a local treating pulmonologist
• Willingness to participate in home phlebotomy and to travel to a local Quest Diagnostics laboratory
• Reside in one of the following states: California, Arizona, Georgia, Louisiana, Minnesota, Oregon