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Clinical Trials/jRCTs051240262
jRCTs051240262RecruitingNot Applicable

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

Not provided0 sites20 target enrollmentStarted: TBDLast updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
20
Primary Endpoint
-
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Single Arm Study
Intervention Model
Single Assignment
Primary Purpose
Treatment Purpose
Masking
Open(masking Not Used)

Eligibility Criteria

Ages
18age old over to No limit (—)
Sex
All

Inclusion Criteria

  • •Who aged 18 years or older at the time of consent
  • •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
  • •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)
  • •Whose treatment for diabetes, hypertension or dyslipidemia (including dietary and exercise therapy) has not changed within 90 days before obtaining consent

Exclusion Criteria

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

Outcomes

Primary Outcomes

-

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

Secondary Outcomes

  • LDL
  • urinary protein (Uprot/Ucre)
  • eGFR
  • body weight
  • TG
  • HDL
  • AST
  • ALT
  • systolic blood pressure
  • diastolic pressure

Investigators

Sponsor
Not provided

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