The efficacy and safety of the pemafibrate in subjects with dyslipidemia and severely decreased renal function; a prospective observational study

The efficacy and safety of the pemafibrate in subjects with dyslipidemia and severely decreased renal function; a prospective observational study - Pema-severe CKD study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000053168

Enrollment

Registered

2023-12-25

Start date

2023-09-19

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia, chronic kidney disease

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria: 1) Subjects with serious liver complications 2) Subjects who are deemed to be unsuitable by the investigator

Design outcomes

Primary

Measure	Time frame
Difference of change in triglyceride after 24 weeks between the pemafibrate and control groups.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Japan

Contacts

Public ContactYuki Oe

Kushiro Red Cross Hospital Internal Medicine

o-e.yuki@med.hokudai.ac.jp0154-22-7171

Outcome results