UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053168 |
|---|---|
| Receipt number | R000060658 |
| Scientific Title | The efficacy and safety of the pemafibrate in subjects with dyslipidemia and severely decreased renal function; a prospective observational study |
| Date of disclosure of the study information | 2023/12/25 |
| Last modified on | 2024/06/10 13:41:40 |
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Basic information
Public title
The efficacy and safety of the pemafibrate in subjects with dyslipidemia and severely decreased renal function; a prospective observational study
Acronym
The efficacy and safety of the pemafibrate in subjects with severely decreased renal function
Scientific Title
The efficacy and safety of the pemafibrate in subjects with dyslipidemia and severely decreased renal function; a prospective observational study
Scientific Title:Acronym
Pema-severe CKD study
Region
| Japan |
Condition
Condition
Dyslipidemia, chronic kidney disease
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objectives of this study are to evaluate the efficacy and safety of switching from EPA and EPA-DHA preparations to pemafibrate in subjects with dyslipidemia and severely decreased renal function.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference of change in triglyceride after 24 weeks between the pemafibrate and control groups.
Key secondary outcomes
The following changes at 4, 12, 24, and 52 weeks from the beginning of the study.
1) Difference of change in eGFR after 24 weeks between the tirzepatide and control groups
2) Renal composite endpoint (doubling of serum creatinine, sustained eGFR decline of 50% or longer, end-stage renal failure (dialysis, renal transplantation, eGFR<15 mL/min/1.73 m2), death from renal disease, etc.)
3) Body weight, waist circumference, body mass index
4) Blood pressure, heart rate
5) Other blood and urine tests (liver, kidney, lipid, bone metabolism, nutrition, endocrine, etc)
6) ABI, CAVI, and PWV in arteriosclerosis testing
7) Dual-energy X-ray absorptiometry
8) Body composition (InBody)
9) Association with participants' background and laboratory data affecting the above items
10) Adverse events reported, including type, severity, etc.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Subjects with triglyceride more than 175 mg/dL
2) Subjects with eGFR less than 30 mL/min/1.73m2
3) Subjects who have been receiving EPA and EPA-DHA preparations for at least 3 months as pre-treatment
4) Subjects aged 20 years or older at the time of consent
5) Those who have received sufficient explanation before participating in this research, and who have obtained the voluntary consent of the research subject after receiving sufficient understanding, or who do not refuse to participate in the research.
Key exclusion criteria
1) Subjects with serious liver complications
2) Subjects who are deemed to be unsuitable by the investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Oe |
Organization
Kushiro Red Cross Hospital
Division name
Internal Medicine
Zip code
060-8638
Address
21-14, Shineichyo, Kushiro, Hokkaido, Japan.
TEL
0154-22-7171
o-e.yuki@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Oe |
Organization
Kushiro Red Cross Hospital
Division name
Internal Medicine
Zip code
060-8638
Address
21-14, Shineichyo, Kushiro, Hokkaido, Japan.
TEL
0154-22-7171
Homepage URL
o-e.yuki@med.hokudai.ac.jp
Sponsor or person
Institute
Kushiro Red Cross Hospital
Institute
Department
Personal name
Yuki Oe
Funding Source
Organization
Kushiro Red Cross Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Kushiro Red Cross Hospital
Address
21-14, Shineichyo, Kushiro, Hokkaido, Japan.
Tel
0154-22-7171
r.cross@kushiro.jrc.or.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 | 25 | 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 | 04 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 19 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The objectives of this study are to evaluate the efficacy and safety of switching from EPA and EPA-DHA preparations to pemafibrate in subjects with dyslipidemia and severely decreased renal function.
Management information
Registered date
| 2023 | Year | 12 | Month | 20 | Day |
Last modified on
| 2024 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060658
