UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063119 |
|---|---|
| Receipt number | R000072234 |
| Scientific Title | Safety and efficacy assessment of nerandomilast administration in patients with interstitial lung disease in a real-world setting: A multicenter prospective observational study |
| Date of disclosure of the study information | 2026/09/30 |
| Last modified on | 2026/09/30 16:14:20 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study of the efficacy and side effects of nelandmilast treatment in patients with interstitial lung disease
Acronym
SANA study
Scientific Title
Safety and efficacy assessment of nerandomilast administration in patients with interstitial lung disease in a real-world setting: A multicenter prospective observational study
Scientific Title:Acronym
SANA study
Region
| Japan |
Condition
Condition
idiopathic pulmonary fibrosis, progressive pulmonary fibrosis
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to prospectively evaluate the real-world efficacy and safety of nerandomilast in patients with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). Additionally, this study examines the associations of patient characteristics, gut microbiota, and concomitant use of other anti-fibrotic agents with treatment outcomes and adverse events, in order to identify predictive factors for these outcomes and events.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Decline in forced vital capacity (FVC) at week 52 after the initiation of nelandmilast
Key secondary outcomes
Survival time, incidence of acute exacerbation, time to first respiratory-related hospitalization, incidence of adverse events.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are scheduled to receive nerandomilast for idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF).
Patients who have received sufficient explanation of the study and provided written informed consent of their own free will.
Key exclusion criteria
Patients aged 17 years or younger at the initiation of nerandomilast.
Patients who are considered inappropriate for participation in this study by the treating physician for any other reason.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tadaaki |
| Middle name | |
| Last name | Yamada |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Pulmonary Medicine, Graduate School of Medical Science
Zip code
602-8566
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
0752515513
tayamada@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Shiho |
| Middle name | |
| Last name | Goda |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Pulmonary Medicine, Graduate School of Medical Science
Zip code
6028566
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
0752515513
Homepage URL
sgoda@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine, Institutional Review Board
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
Tel
0752515111
rinri@koto.kpu-m.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
京都府立医科大学附属病院（京都府）
京都府立医科大学附属北部医療センター（京都府）
宇治徳洲会病院（京都府）
淡海医療センター（滋賀県）
大阪府済生会吹田病院（大阪府）
京都第一赤十字病院（京都府）
京都第二赤十字病院（京都府）
京都中部総合医療センター（京都府）
神戸中央病院（兵庫県）
済生会滋賀県病院（滋賀県）
市立大津市民病院（滋賀県）
市立福知山市民病院（京都府）
獨協医科大学埼玉医療センター（埼玉県）
洛和会音羽病院（京都府）
福岡大学病院（福岡県）
藤田医科大学（愛知県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2026 | Year | 08 | Month | 13 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 18 | Day |
Last follow-up date
| 2031 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a multicenter prospective observational study. Patients with idiopathic pulmonary fibrosis or progressive pulmonary fibrosis who are scheduled to receive nerandomilast as part of routine clinical practice at participating facilities will be prospectively enrolled if they meet the eligibility criteria and provide written informed consent.
Clinical information will be prospectively collected to evaluate the decline in forced vital capacity (FVC) at 52 weeks after the initiation of nerandomilast, survival, incidence of acute exacerbation, time to first hospitalization, and incidence of adverse events. Additionally, the gut microbiota composition prior to the start of treatment will be analyzed. The study aims to evaluate the real-world efficacy and safety of nerandomilast and to identify factors associated with treatment outcomes and safety. The planned sample size is 100 patients.
Management information
Registered date
| 2026 | Year | 09 | Month | 30 | Day |
Last modified on
| 2026 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072234
