The efficacy and safety of the pemafibrate in subjects with dyslipidemia and severely decreased renal function; a prospective observational study
Not Applicable
Recruiting
- Conditions
- Dyslipidemia, chronic kidney disease
- Registration Number
- JPRN-UMIN000053168
- Lead Sponsor
- Kushiro Red Cross Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Not provided
Exclusion Criteria
1) Subjects with serious liver complications 2) Subjects who are deemed to be unsuitable by the investigator
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference of change in triglyceride after 24 weeks between the pemafibrate and control groups.
- Secondary Outcome Measures
Name Time Method 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.