UMIN-ICDS 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 2023/12/20 08:28:33

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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

60


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

Email

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


Email

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

Email

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

2023 Year 12 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060658


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name