EDEN study

JRCT ID: jRCTs051240262

Registered date:05/02/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: CKD with Dyslipidemia
• Date of first enrollment: 05/02/2025
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Intake of D-alanine

Outcome(s)

• Primary Outcome: Changes in serum TG/HDL ratio 4 weeks after administration of D-alanine
• Secondary Outcome: Changes in TG, HDL, LDL, AST, ALT, systolic blood pressure, diastolic pressure, urinary protein (Uprot/Ucre), eGFR and body weight

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Who aged 18 years or older at the time of consent
2) Who meet either and or both of the following renal criteria within 60 days before enrollment
A) eGFR less than 60mL/min/1.73m2
B) Urinary protein/urinary creatine ratio of 0.15 g/gcre or higher
3) Who have an elevated fasting TG/HDL ratio within 28 days before enrollment(2.967 or higher for men, 2.237 or higher for women)
4) Whose treatment for diabetes, hypertension or dyslipidemia (including dietary and exercise therapy) has not changed within 90 days before obtaining consent

Exclude criteria

1) Who have taken fibrates, selective PPARalpha modulators, or n3-polyunsaturated fatty acids within 90 days before obtaining consent
2) With TG levels of 500 mg/dL or higher
3) Who are pregnant, breastfeeding, or planning to be pregnant during study period
4) With poorly controlled(glycated A1c(NGSP) > 10%)
5) With uncontrolled hypertension despite optimal antihypertensive agents(either systolic blood pressure >=180 mmHg or diastolic blood pressure >=110mmHg)
6) With severe liver dysfunction(AST(GOT) or ALT(GPT) >=100 IU/L)
7) With severe renal dysfunction(eGFR < 30 mL/min/1.73m2)
8) With a concurrent malignancy
9) Who participated in another clinical trial (interventional study) within 90 days prior to the study drug administration
10) Whom the principal investigator or sub-investigator deems inappropriate for study participation

Related Information

• Primary Sponsor: Matsui Masaru
• Source(s) of Monetary Support: Nara Medical University