UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054527 |
|---|---|
| Receipt number | R000062237 |
| Scientific Title | Investigation of finerenone's inhibition of kidney, lung, and liver fibrosis and progression of organ damage in rheumatoid arthritis patients with diabetes and chronic kidney disease |
| Date of disclosure of the study information | 2024/07/31 |
| Last modified on | 2024/05/31 11:24:46 |
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Basic information
Public title
Investigation of finerenone's inhibition of kidney, lung, and liver fibrosis and progression of organ damage in rheumatoid arthritis patients with diabetes and chronic kidney disease
Acronym
Finerenone trial in Gifu
Scientific Title
Investigation of finerenone's inhibition of kidney, lung, and liver fibrosis and progression of organ damage in rheumatoid arthritis patients with diabetes and chronic kidney disease
Scientific Title:Acronym
Finerenone trial in Gifu
Region
| Japan |
Condition
Condition
Rheumatoid arthritis with diabetes and chronic kidney disease
Classification by specialty
| Gastroenterology | Pneumology | Endocrinology and Metabolism |
| Nephrology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether administration of finerenone inhibits the onset and progression of fibrosis in the kidney, lung, and liver in rheumatoid arthritis patients with diabetes and chronic kidney disease.
Finerenone, a nonsteroidal selective mineralocorticoid receptor antagonist, was launched in June 2022 for chronic kidney disease associated with type 2 diabetes. Finerenone binds to the mineralocorticoid receptor (MR) and inhibits MR overactivation. MR is widely distributed and expressed throughout the body, including epithelial tissues such as renal tubules, as well as renal glomeruli, the heart, and blood vessels. Overactivation of MR causes electrolyte dysregulation and inflammation and fibrosis in various tissues. Finerenone suppressed inflammation and fibrosis in organ dysfunction model animals, and demonstrated inhibitory effects such as reducing renal dysfunction and suppressing renal hypertrophy and the occurrence of proteinuria. On the other hand, rheumatoid arthritis is a disease that causes damage due to inflammation not only in the joints but also in organs. In this aspect, it exhibits fibrosis originating from these inflammations and the associated functional disorders. It is assumed that MR is overexpressed and overactivated in rheumatoid arthritis complicated by chronic kidney disease due to type 2 diabetes as described above, and there have been no reports yet on the effect of finerenone administration in these patients in suppressing renal, pulmonary, and hepatic fibrosis, or the progression of functional impairment. If it is possible to achieve anti-inflammatory and anti-fibrotic effects without relying on steroids, and to suppress subsequent functional impairment, it would be a major discovery in the field of rheumatism and collagen disease. We believe it is worthwhile to examine whether this can be achieved with finerenone.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Primary endpoint
Improvement of fibrosis markers in each organ at 52 weeks of administration compared to before administration of finerenone (lung... KL-6, SP-D, liver...hyaluronic acid, M2BPGi, FIB4index, kidney...urinary and blood beta 2 microglobulin, urinary NAG)
Key secondary outcomes
Secondary endpoints
Improvement and change rate of fibrosis markers in each organ, respiratory function, eGFR, UPCR and UACR, PRO index, and CT images in the finerenone group before administration, and at 4, 12, 24, and 52 weeks of administration, and comparison of these items with the non-finerenone group
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 with rheumatoid arthritis and diabetes mellitus who are aged 18 years or older, regardless of gender or whether they are in an outpatient or hospitalized setting. Patients who meet the diagnostic criteria for diabetes (fasting blood glucose 126 mg/dL or higher, 2-hour value 200 mg/dL or higher, HbA1c 6.5% or higher) or who have met the criteria in the past and have been diagnosed with diabetes, and who have stage 2 diabetic nephropathy (urinary microalbumin/creatinine ratio 30-299 mg/gCRE), stage 3 diabetic nephropathy (urinary microalbumin/creatinine ratio 300 mg/gCRE or higher), stage 4 diabetic nephropathy (estimated glomerular filtration rate (eGFR) 30 mL/min/1.73 m2 or lower), or stage 2 chronic kidney disease with diabetes (eGFR less than 89 mL/min/1.73 m2) or higher.
Key exclusion criteria
Patients with hypersensitivity to finerenone
Patients who meet the contraindications listed in the package insert for finerenone (patients with a history of hypersensitivity to the ingredients of this drug, patients receiving preparations containing itraconazole/ritonavir, preparations containing atazanavir/darunavir/fosamprenavir/cobicistat, patients receiving clarithromycin/ensitrevir, patients with serum potassium levels exceeding 5.5mEq/L at the start of administration of this drug, patients with severe liver dysfunction (Child-Pugh classification C), patients with taste impairment)
Patients who have experienced adverse effects after administration of finerenone and have difficulty continuing administration
Patients who are currently receiving or have previously received finerenone or drugs with a similar mechanism of action, such as esaxerenone, eplerenone, or spironolactone
Patients who have requested to discontinue this study by opting out
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Hideyuki |
| Middle name | |
| Last name | Okada |
Organization
Gifu Prefectural General Medical Center
Division name
Department of General Internal medicine and Rheumatology
Zip code
5008717
Address
Noishiki 4-6-1 Gifu-city Gifu
TEL
0582461111
hideyuki_okada_0920@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hideyuki |
| Middle name | |
| Last name | Okada |
Organization
Gifu Prefectural General Medical Center
Division name
Department of General Intrenal Medicine and Rheumatology
Zip code
5008717
Address
Noishiki 4-6-1 Gifu-city Gifu
TEL
0582461111
Homepage URL
hideyuki_okada_0920@yahoo.co.jp
Sponsor or person
Institute
Gifu Prefectural Medical Center, Department of General Internal Medicine and Rheumatology, Hideyuki Okada
Institute
Department
Personal name
Funding Source
Organization
No
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
Gifu Prefectural General Medical Center
Address
Noishiki 4-6-1 Gifu-city Gifu
Tel
0582461111
hideyuki_okada_0920@yahoo.co.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 31 | 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
| 2024 | Year | 04 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study enrollment has begun(1,May,2024)
Management information
Registered date
| 2024 | Year | 05 | Month | 31 | Day |
Last modified on
| 2024 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062237
