UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053038 |
|---|---|
| Receipt number | R000060512 |
| Scientific Title | Elucidation of the role of Receptor activator of nuclear factor kappa-B (RANK)/RANK ligand (RANKL) signals in the onset and progression of primary biliary cholangitis |
| Date of disclosure of the study information | 2023/12/08 |
| Last modified on | 2023/12/08 21:12:17 |
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Basic information
Public title
Elucidation of the role of Receptor activator of nuclear factor kappa-B (RANK)/RANK ligand (RANKL) signals in the onset and progression of primary biliary cholangitis
Acronym
Elucidation of the role of Receptor activator of nuclear factor kappa-B (RANK)/RANK ligand (RANKL) signals in the onset and progression of primary biliary cholangitis
Scientific Title
Elucidation of the role of Receptor activator of nuclear factor kappa-B (RANK)/RANK ligand (RANKL) signals in the onset and progression of primary biliary cholangitis
Scientific Title:Acronym
Elucidation of the role of Receptor activator of nuclear factor kappa-B (RANK)/RANK ligand (RANKL) signals in the onset and progression of primary biliary cholangitis
Region
| Japan |
Condition
Condition
primary biliary cholangitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the influence of RANK/RANKL signals on the pathology of PBC
Basic objectives2
Others
Basic objectives -Others
Changes in the number of RANK, RANKL and OPG positive cells in the liver from baseline to 12 months after treatment
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in the number of RANK/RANKL/OPG positive cells in the liver from baseline to 12 months after treatment.Patients with osteoporosis are treated with denosumab + UDCA, and patients without osteoporosis are treated with UDCA alone.
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 89 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with PBC
Key exclusion criteria
Hypocalcemia (corrected serum calcium level less than 8.4mg/dl)
Severe renal dysfunction (eGFR 35 < mL/min/1.73m2)
Child-Pugh classification grade B or C
Total bilirubin level is 5 mg/dl or more
Concomitant with ascites
Complicated by poorly controlled hepatic encephalopathy
Complicated by uncontrolled malignant tumor
Requires dental treatment
Taking corticosteroids
Patients with a history of hypersensitivity to denosumab
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Arase |
Organization
Tokai University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
259-1193
Address
143 Shimokasuya, Isehara, Kanagawa
TEL
0463-93-1121
arase@tokai-u.jp
Public contact
Name of contact person
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Arase |
Organization
Tokai University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
259-1193
Address
143 Shimokasuya, Isehara, Kanagawa
TEL
0463-93-1121
Homepage URL
arase@tokai-u.jp
Sponsor or person
Institute
Tokai University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokai University School of Medicine, IRB
Address
143 Shimokasuya, Isehara, Kanagawa
Tel
0463-93-1121
arase@tokai-u.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
| 2023 | Year | 12 | Month | 08 | 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
| 2023 | Year | 09 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 02 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2023 | Year | 12 | Month | 08 | Day |
Last modified on
| 2023 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060512
