Efficacy of D-alanine intake in patients with chronic kidney disease; a randomized controlled pilot trial

Efficacy of D-alanine intake in patients with chronic kidney disease; a randomized controlled pilot trial - D-alanine CKD pilot trial

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs041230148

Enrollment

Registered

2024-02-06

Start date

2024-07-26

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

Chronic kidney disease Chronic kidney disease

Interventions

D-alanine 1 g, per oral, three times a day after each meal for 12 weeks

D000409

D-amino acids

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who meet all of the following criteria are included. 1) Patients who aged 20 years or older at the time of obtaining the informed consent. 2) Sustained urine protein to creatinine ratio higher than 0.5 g/gCr or urine albumin to creatine ratio higher than 300 mg/gCr for more than two consecutive visits 3) The written consent can be obtained after informed consent for participation in the study.

Exclusion criteria

Exclusion criteria: Patients who meet any of the following criteria are excluded. 1) Patients undergoing dialysis therapy 2) Pregnant or lactating mothers 3) Patinets who take antimicrobials or medications for intestine disorders including lactobacillus preparations 4) Patients who take food for specified health uses or food with functional claims that labels the improvement of the intestinal environment at the study entry 5) Initiation of SGLT2 inhibitors within 8 weeks prior to the study entry 6) Initiation of RAS blockers within 8 weeks prior to the study entry 7) Participation in other clinical studies within 8 weeks prior to the study entry 8) Not appropriate as participants

Design outcomes

Primary

Measure	Time frame
Percentage change in urine albumin to creatine ratio from baseline to 12 weeks	—

Secondary

Measure	Time frame
1) Changes in the variables from baseline to 12 weeks; blood glucose, HbA1c, blood pressure, BMI, estimated GFR, uric acid, fasting blood glucose, HbA1c, T-Cho, HDL-Cho, TG, urine protein/creatinine ratio, urine beta-2-microglobulin, urine NAG, urine MCP-1, sleep index, sarcopenia assessment, chiral amino acids (blood, urine, stool, saliva), 16S rRNA flora (stool, saliva) 2) Remission of albuminuria 3) Adverse events	—

Measure

Time frame

1) Changes in the variables from baseline to 12 weeks; blood glucose, HbA1c, blood pressure, BMI, estimated GFR, uric acid, fasting blood glucose, HbA1c, T-Cho, HDL-Cho, TG, urine protein/creatinine ratio, urine beta-2-microglobulin, urine NAG, urine MCP-1, sleep index, sarcopenia assessment, chiral amino acids (blood, urine, stool, saliva), 16S rRNA flora (stool, saliva) 2) Remission of albuminuria 3) Adverse events

—

Contacts

Public ContactMegumi Oshima

Kanazawa University Hospital

moshima@staff.kanazawa-u.ac.jp+81-76-254-2499

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026