NERAM-PF
Nerandomilast Added to Mycophenolate for Treatment of Pulmonary Fibrosis (NERAM-PF).
Sponsor study identifier
interventional
120
0 countries
N/A
Study Start
June 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This is a trial designed to evaluate the combination of nerandomilast with mycophenolate across a wide variety of pulmonary fibrosis subtypes, with the aim of providing clinicians with assurance that this is an appropriate therapeutic combination.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 27, 2026
Actual (reported)May 6, 2026
Actual (reported)June 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
July 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Determine the persistency of nerandomilast at 4 months when used in combination with mycophenolate in patients with pulmonary fibrosis
The primary outcome will be the frequency of persistent nerandomilast use at 4 months, recorded as a dichotomous variable. To account for the proportion of patients with persisting use of nerandomilast at 4 months after baseline, the percentage of days treated will be recorderd based on patient report and verified against drug dispensation records and 4-month pill counts. Pre-specified analyses will include evaluation of rate of discontinuation of nerandomilast across specific variables, including age, sex, body weight, total daily dose of mycophenolate, and total daily dose of mycophenolate adjusted for body weight. This outcome will support the main hypothesis that, when combined with mycophenolate, nerandomilast will achieve a persistency of ≥ 80% ongoing use at 4 months
Four months
Determine the frequency of adverse events associated with nerandomilast
Four months
Compare rate of change in forced vital capacity (FVC) in patients treated with nerandomilast to pre-treatment rate of change
Four months
Compare rate of change in diffusion capacity of the lung for carbon monoxide (DLCO) in patients treated with nerandomilast to pre-treatment rate of change
Four months
Determine the rate of change in patient-reported outcome measures (PROMs) from baseline to month 4
Four months
Analysis of blood-based biomarkers including telomere length influence on the response to nerandomilast, alongside treatment-associated alterations in DNA methylation, as measured by change in FVC and DLCO.
Four months
Participant who are already treated with mycophenolate and have pulmonary fibrosis will receive also treatment with nerandomilast.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
First Submitted
April 27, 2026
First Posted
May 6, 2026
Study Start
June 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The Study of the Use of Nintedanib in Slowing Lung Disease in Patients With Fibrotic or Non-Fibrotic Interstitial Lung Disease Related to COVID-19
Contact the study team to confirm eligibility.
Primary Completion
June 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 11, 2026
Record last verified: 2026-03
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Source: ClinicalTrials.gov.
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