臨床研究等提出・公開システム

Effects of D-alanine on Lipid metabolism in patients with CKD (EDEN study)

EDEN study

Matsui Masaru

Nara Medical University Hospital

840 Shijo-cho, Kashihara, Nara, JAPAN

masaru@naramed-u.ac.jp

Matsui Masaru

Nara Medical University Hospital

840 Shijo-cho, Kashihara, Nara, JAPAN

+81-744-22-3051

masaru@naramed-u.ac.jp

Recruiting

Feb. 05, 2025

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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 60 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

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

Both

CKD with Dyslipidemia

Intake of D-alanine

Changes in serum TG/HDL ratio 4 weeks after administration of D-alanine

Changes in TG, HDL, LDL, AST, ALT, systolic blood pressure, diastolic pressure, urinary protein (Uprot/Ucre), eGFR and body weight

+81-744-29-8835

Dec. 18, 2024

No

none