Real-world Study of Nerandomilast in Patients With Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis
NCT07919015, Recruiting, Avraham Unterman
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Real-world Study of Nerandomilast in Patients With Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis | ClinicalTrials.gov |
| NCT number | NCT07919015 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Enrollment | 70 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Avraham Unterman | ClinicalTrials.gov |
| Conditions | Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis | ClinicalTrials.gov |
| Interventions | Nerandomilast | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-05 | ClinicalTrials.gov |
Registered outcomes 15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Adverse events | Through study completion, an average of 9 months | Proportion of participants experiencing prespecified adverse events (diarrhea, weight loss, nausea, cough, upper respiratory tract infection, dyspnea, nasopharyngitis, worsening of underlying condition, depression, anxiety), reported overall and by severity. | ClinicalTrials.gov |
| Secondary | Difference between the pre-treatment and on-treatment annualized rate of FVC decline (mL/year) | Up to 24 months before initiation and, on average, 6 months after initiation | Average for all participants. For each participant, the annualized slope of absolute forced vital capacity over the period preceding nerandomilast initiation (derived from at least two pre-treatment measurements obtained within the previous 24 months) is compared with the annualized slope during 12 months of treatment. Each participant serves as their own control; the outcome is the within-participant difference between the two slopes, in mL/year, with a positive value indicating attenuation of decline on treatment. | ClinicalTrials.gov |
| Secondary | Difference between pre-treatment and on-treatment annualized rate of FVC decline (% predicted/year) | Up to 24 months before initiation and, on average, 6 months after initiation | As for outcome 2, with FVC expressed as percentage of predicted value. | ClinicalTrials.gov |
| Secondary | Difference between pre-treatment and on-treatment annualized rate of DLCO decline (% predicted/year) | Up to 24 months before initiation and, on average, 6 months after initiation | As above, for diffusing capacity of the lungs for carbon monoxide, corrected for hemoglobin. | ClinicalTrials.gov |
| Secondary | Change from baseline in K-BILD domain scores | Baseline and 6-12 months | Breathlessness and activities, psychological, and chest symptoms domains, each scored 0-100, higher indicating better health status. | ClinicalTrials.gov |
| Secondary | Change from baseline in FVC (mL and % predicted) | Baseline and >6 months | Absolute annualized change in forced vital capacity from the pre-treatment baseline measurement. | ClinicalTrials.gov |
| Secondary | Change from baseline in DLCO (% predicted) | Baseline and >6 months | Absolute annualized change in hemoglobin-corrected diffusing capacity from the pre-treatment baseline measurement. | ClinicalTrials.gov |
| Secondary | Incidence of serious adverse events | Through study completion, an average of 9 months | Proportion of participants with at least one serious adverse event, defined as an event that is fatal, life-threatening, requires or prolongs hospitalization, or results in persistent or clinically significant disability. | ClinicalTrials.gov |
| Secondary | Permanent discontinuation of nerandomilast | Through study completion, an average of 9 months | Proportion of participants permanently discontinuing nerandomilast, time to discontinuation, and reason for discontinuation. | ClinicalTrials.gov |
| Secondary | Dose reduction of nerandomilast | Through study completion, an average of 9 months | Proportion of participants in whom nerandomilast dose is reduced, time to dose reduction, and reason for dose reduction. | ClinicalTrials.gov |
| Secondary | Annualized incidence of acute exacerbation of interstitial lung disease | Through study completion, an average of 9 months | Number and proportion of participants with at least one acute exacerbation, defined according to published criteria, time to exacerbation. | ClinicalTrials.gov |
| Secondary | Annualized incidence of respiratory-cause hospitalization | Through study completion, an average of 9 months | Annualized incidence of respiratory-cause hospitalization | ClinicalTrials.gov |
| Secondary | Annualized all-cause mortality | Through study completion, an average of 9 months | Proportion of participants who die from any cause during follow-up. | ClinicalTrials.gov |
| Secondary | Annualized incidence of lung transplantation | Through study completion, an average of 9 months | Proportion of participants undergoing lung transplantation during follow-up. | ClinicalTrials.gov |
| Secondary | Exploratory: Outcomes stratified by diagnosis, nerandomilast dosage, and background antifibrotic therapy | Through study completion, an average of 9 months | Primary and key secondary outcomes reported separately for IPF versus PPF, and for background nintedanib, pirfenidone, or no background antifibrotic therapy. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)