UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056102 |
|---|---|
| Receipt number | R000064085 |
| Scientific Title | Study on the Efficacy of Pemafibrate in Patients with Dyslipidemia ~A Study of the Efficacy of Apo B48 in Improving~ A Multicenter, Open-Label, Randomized, Parallel Group Study (PROUD48) Sub-analysis |
| Date of disclosure of the study information | 2024/11/08 |
| Last modified on | 2024/11/11 08:51:07 |
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Basic information
Public title
Study on the Efficacy of Pemafibrate in Patients with Dyslipidemia
~A Study of the Efficacy of Apo B48 in Improving~
A Multicenter, Open-Label, Randomized, Parallel Group Study (PROUD48)
Sub-analysis
Acronym
PROUD48 Sub-analysis
Scientific Title
Study on the Efficacy of Pemafibrate in Patients with Dyslipidemia
~A Study of the Efficacy of Apo B48 in Improving~
A Multicenter, Open-Label, Randomized, Parallel Group Study (PROUD48)
Sub-analysis
Scientific Title:Acronym
PROUD48 Sub-analysis
Region
| Japan |
Condition
Condition
Dyslipidemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
As a subanalysis of the PROUD48 study, residual blood samples from the PROUD48 study will be used to measure cholesterol uptake capacity of HDL and other atherosclerosis-related indicators to compare and verify differences between the pemafibrate and ethyl omega-3 fatty acid treatment groups
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cholesterol uptake capacity of HDL at 16 weeks
Key secondary outcomes
FABP1, FABP4, FABP5, FABP6, PCSK9, IL-1beta, IL-6, hs-CRP, sTNF-R1, sTNF-R2, EphA2, DLL4, GDF15, adiponectin, FGF21, TSK, PCSK7, TfR1, ACE2 change, percent change
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects who participated in the PROUD48 study (*For validation using residual specimens, patients with sufficient blood sample volume for measurement of various items will be included)
Key exclusion criteria
Patients who have indicated their refusal by opting out
Patients who do not have blood samples on file at the time of evaluation Principal Investigator
Target sample size
129
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Sakuma |
Organization
Social Medical Corporation Caress Sapporo Hokko Memorial Clinic
Division name
department of internal medicine
Zip code
065-0027
Address
8-1-6, Kita 27-jo Higashi, Higashi-ku, Sapporo, Hokkaido
TEL
011-722-1133
sakuichi@seagreen.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Ichiro |
| Middle name | |
| Last name | Sakuma |
Organization
Social Medical Corporation Caress Sapporo Hokko Memorial Clinic
Division name
department of internal medicine
Zip code
065-0027
Address
8-1-6, Kita 27-jo Higashi, Higashi-ku, Sapporo, Hokkaido
TEL
011-722-1133
Homepage URL
sakuichi@seagreen.ocn.ne.jp
Sponsor or person
Institute
Social Medical Corporation Caress Sapporo Hokko Memorial Clinic
Institute
Department
Personal name
Ichiro Sakuma
Funding Source
Organization
Kowa Corporation
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Board for Life Sciences and Medical Research Involving Human Subjects
Address
207 Aza-Uehara, Nishihara-cho, Okinawa, Japan
Tel
0988951542
krinken@acs.u-ryukyu.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Preinitiation
Date of protocol fixation
| 2024 | Year | 07 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
Using residual blood samples from the PROUD48 study collected during fasting (at least 10 hours after eating), the following items will be measured to compare and validate differences between the pemafibrate and ethyl omega-3 fatty acid treatment groups.
Cholesterol uptake capacity of HDL
FABP1*, FABP4*, FABP5*, and FABP6*.
PCSK9*, IL-1beta*, IL-1beta*, and IL-1beta*.
IL-1beta*, IL-6*, hs-CRP*, sTNF-R1*, sTNF-R2*, EphA2*, DLL4*, GDF15*, Adiponectin
Adiponectin*, FGF21*, TSK*, PCSK7*, TfR1*, TfR1
ACE2*.
In addition, we will examine the association between the above atherosclerosis-related indices and the patient background and various clinical indices already collected in the main study.
ApoA1 antibody will be used to measure the amount of cholesterol in HDL collected after adding labeled cholesterol to serum at Sysmex.
*Measurement will be performed at Sapporo Medical University using various assays.
Various clinical indices: age, sex, height, weight, abdominal circumference diameter, BMI, blood pressure, lean body mass, body fat mass, muscle mass, L/S ratio, visceral fat area, duration of diabetes, family history of diabetes, comorbidities (hypertension, diabetic nephropathy, diabetic retinopathy, diabetic neuropathy, other renal diseases, liver diseases, cerebrovascular diseases, presence of cardiovascular diseases), history history (presence or absence of cerebrovascular disease), alcohol consumption and smoking, concomitant medications (antihypertensive medications, dyslipidemia medications, antiplatelet medications, diabetes medications), medication compliance with study medications, apoB48, RLP-C, small dense LDL-C, TG, TC, HDL-C, LDL-C, apoAI, apoAII, apoB, apo CII, apo CIII, apo E, lipoprotein fraction (HPLC method), glucose, HbA1c, insulin, HOMA-IR, HOMA-beta, AST, ALT, gamma-GTP, ALP, serum creatinine, eGFR, CK, fibrinogen
Management information
Registered date
| 2024 | Year | 11 | Month | 08 | Day |
Last modified on
| 2024 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064085
