UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052625 |
|---|---|
| Receipt number | R000060051 |
| Scientific Title | The exploratory observational study of the usefulness of pemafibrate in lipid management of primary dyslipidemia |
| Date of disclosure of the study information | 2023/11/01 |
| Last modified on | 2026/04/30 16:26:56 |
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Basic information
Public title
The exploratory observational study of the usefulness of pemafibrate in lipid management of primary dyslipidemia
Acronym
PEMA-PD(PEMAfibrate-Primary Dyslipidemia)
Scientific Title
The exploratory observational study of the usefulness of pemafibrate in lipid management of primary dyslipidemia
Scientific Title:Acronym
PEMA-PD(PEMAfibrate-Primary Dyslipidemia)
Region
| Japan |
Condition
Condition
Primary dyslipidemia
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to exploratively collect data on the usefulness of pemafibrate in patients with primary dyslipidemia, especially CETP deficiency and familial type III hyperlipidemia (ApoE mutation).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in triglyceride levels from baseline
Key secondary outcomes
Changes in lipids and various clinical parameters at each point. Adverse events and side effects.
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
1) Patients with diagnosed or suspected primary dyslipidemia (suspected CETP deficiency, HDL-C of 100 mg/dL or higher; suspected familial type III hyperlipidemia, following the diagnostic criteria in the Japan Atherosclerosis Society Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2022.)
2) Patients who have received pemafibrate from May 2018 through the date of informed consent, or patients who will receive pemafibrate due to therapeutic need by September 30, 2024.
3) Patients at 18 years of age or older on the date of informed consent.
4) Patients who have given their written informed consent to participate in this study.
Key exclusion criteria
Patients considered to be inappropriate for participation in this study at the discretion of principal investigator or sub-investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Shizuya |
| Middle name | |
| Last name | Yamashita |
Organization
Rinku General Medical Center
Division name
Department of Cardiology
Zip code
598-8577
Address
2-23 Ourai-kita, Rinku, Izumisano, Osaka 598-8577, Japan
TEL
072-469-3111
s-yamashita@rgmc.izumisano.osaka.jp
Public contact
Name of contact person
| 1st name | Daisaku |
| Middle name | |
| Last name | Masuda |
Organization
Rinku General Medical Center
Division name
Department of Cardiology
Zip code
598-8577
Address
2-23 Ourai-kita, Rinku, Izumisano, Osaka 598-8577, Japan
TEL
072-469-3111
Homepage URL
d-masuda@rgmc.izumisano.osaka.jp
Sponsor or person
Institute
Rinku General Medical Center
Institute
Department
Personal name
Funding Source
Organization
Kowa Company, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB, Rinku General Medical Center
Address
2-23 Ourai-kita, Rinku, Izumisano, Osaka 598-8577, Japan
Tel
072-469-3111
j-chiken@rgmc.izumisano.osaka.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
地方独立行政法人りんくう総合医療センター（大阪府）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.rgmc.izumisano.osaka.jp/about/information/clinical/
Publication of results
Published
Result
URL related to results and publications
https://www.rgmc.izumisano.osaka.jp/about/information/clinical/
Number of participants that the trial has enrolled
5
Results
In patients with CETP deficiency and high remnant cholesterol level, treatment with pemafibrate effectively reduced triglyceride levels in all cases. No complications associated with the treatment were observed. Furthermore, analysis of the lipoprotein profile using HPLC revealed, as in previous studies, a reduction in the remnant content of VLDL and LDL in patients with high remnant cholesterol level. No changes specific to CETP deficiency were observed.
Results date posted
| 2026 | Year | 04 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Two cases of CETP deficiency and three cases of high-remnant cholesterol level, selected in accordance with the protocol
Participant flow
Two cases of CETP deficiency and three cases of high-remnant cholesterol level, selected in accordance with the protocol. In all cases, patients were administered pemafibrate and blood samples were taken before and after treatment in accordance with the protocol.
Adverse events
None
Outcome measures
*Various Observation Items
(1) Physical Examination
- Height, Weight, BMI (calculated), Waist circumference, Blood pressure
(2) Blood Test
- Lipid parameters: TG, TC, HDL-C, LDL-C, Apo A-I, Apo A-II, Apo B, Apo B-48, Apo C-II, Apo C-III, Apo E, Lp(a), RemL-C, Lipoprotein fraction (PAGE), non-HDL-C (calculated), TG/HDL-C (calculated)
- Glucose-related parameters: FPG, HbA1c
- Liver-related parameters: AST, ALT, ALP, G-GTP
- Renal-related parameters: Cr, eGFR (calculated)
- Thyroid-related parameters: FT3, FT4, TSH
(3) Adverse Events, Side Effects
- Adverse events, side effects, and outcomes occurring after the start of study drug administration
(4) Genetic Testing, etc.
- Patients with CETP deficiency: CETP protein level, Lipoprotein fraction (GP-HPLC)
- Patients suspected of CETP deficiency: CETP genetic testing, CETP protein level, Lipoprotein fraction (GP-HPLC)
- Patients with Familial Type III Hyperlipoproteinemia: Lipoprotein fraction (GP-HPLC)
- Patients suspected of Familial Type III Hyperlipoproteinemia: ApoE isoform, Lipoprotein fraction (GP-HPLC)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 13 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 06 | Month | 30 | Day |
Other
Other related information
This prospective, observational, exploratory study (including some retrospective cases) aims to collect data on the effectiveness and safety of pemafibrate in patients with primary dyslipidemia, particularly CETP deficiency and familial type III hyperlipidemia (ApoE mutation). This study will collect data on all eligible patients who give their consent during the study period.
Management information
Registered date
| 2023 | Year | 10 | Month | 26 | Day |
Last modified on
| 2026 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060051
