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New treatment option for Idiopathic Pulmonary Fibrosis
Official title Zinc and Nicotinamide Riboside for Idiopathic Pulmonary Fibrosis
ClinicalTrials.gov ID: NCT06567717
What this study is testing
What is Zinc?
Zinc is an investigational medicine, given as a twice-daily, being studied as a potential treatment for idiopathic pulmonary fibrosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to learn if a clinical trial for idiopathic pulmonary fibrosis (IPF) can recruit and retain participants from their home to study whether a combination of zinc and nicotinamide riboside can treat iIPF. The main questions are: Can the investigators recruit participants, and can participants complete study procedures without physically coming into specific clinical trial sites?
- Phase 2: a mid-size study of how well it works
- Time commitment: about 52 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- 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 \> 50 years
- Confident diagnosis of IPF per the latest ATS/ERS/JRS/ALAT Clinical Practice Guideline on Diagnosis of IPF10
You likely can't join if
- 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...
- Evidence of secondary etiologies of ILD (signs/symptoms of connective tissue disease, including ANA titer \> 1:80, history of exposures related to...
- Evidence of comorbid pulmonary pathology including but not limited to asthma, tuberculosis, sarcoidosis, chronic infections
- Any acute illness or febrile event that has not resolved at least 14 days prior to either screening or the first study visit
- Use of tobacco-containing products within the last 3 months and/or unwillingness to abstain from use for the duration of the study
- Participation in a clinical study involving administration of other investigational drugs in the 30 days prior to screening
See the full eligibility criteria
Who can join
- 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 \> 50 years
- Confident diagnosis of IPF per the latest ATS/ERS/JRS/ALAT Clinical Practice Guideline on Diagnosis of IPF10
- people must have a high-resolution computed tomography (HRCT) completed in the 6 months as part of their standard of care prior to informed consent
- people must have HRCT pattern of definite or probable UIP
- people 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
What rules you out
- 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...
- 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...
- Evidence of comorbid pulmonary pathology including but not limited to asthma, tuberculosis, sarcoidosis, chronic infections
- Any acute illness or febrile event that has not resolved at least 14 days prior to either screening or the first study visit
- Use of tobacco-containing products within the last 3 months and/or unwillingness to abstain from use for the duration of the study
- Participation in a clinical study involving administration of other investigational drugs in the 30 days prior to screening
- 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
- Inability to obtain reproducible, high-quality pulmonary function tests
- 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 prednisone usage at a dose \> 10 mg daily
- Chronic use of any restricted medications known to have significant interactions with zinc supplementation (see Section 6.5)
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
- 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...
- 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
- 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
- Prior allogeneic stem cell or solid organ transplantation
- 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 study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 52 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.