None listed
Conditions
Interventions
Dietary Supplement : <
Test drug>
: Take KBL409 558mg / capsule, once a day, oral, once a capsule 30 minutes before meals
<
Placebo>
Ingredient name: Destrin / Form and Formulation: Same as test food
Content: 558mg / Capsule
Usage and Dosage: Take 1 capsule once a day with water at 30 minutes before meal
Storage method: Refrigerate
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Person over 19 years old 2) Person whose glomerular filtration rate (eGFR (Estimated Glomerular Filtration Rate)) measured at Visits 1 and 2 is 30 mL / min / 1.73 m2 or more 3) Person who have a UPCR (Urine Protein / Creatinine Ratio) of 0.5g / g or more measured at Visits 1 and 2 4) person who agrees to participate in this human trial and signs the informed consent form before the human application test begins
Exclusion criteria
Exclusion criteria: 1) Those who need kidney dialysis 2) Those who have had a kidney transplant 3) Person suffering from glomerulonephritis (one who has not recurred in the past year and does not use immunosuppressants can register) 4) Those who have taken medications for the purpose of renal therapy (Kremezin, Renamezin, Tolvaptan, etc.) other than hypertension and diabetes treatment within 4 weeks of Visit 1 5) Person using immunosuppressants 6) Those who received systemic antibiotics within 2 weeks of Visit 1 7) Those who consumed probiotics and fermented milk or formal drug within 2 weeks of Visit 1 8) Those who are sensitive or allergic to food ingredients for human testing 9) Those who are being treated for thyroid disease 10) Person whose AST (GOT) or ALT (GPT) is 3 times higher than the normal upper limit 11) Participants in other interventional trials (including human trials) within one month of the start of the human application test, or plan to participate in other interventions (including human trials) after the start of the human application test 12) A person who is pregnant, lactating or planning to become pregnant during this human application test period 13) A person judged by the investigator to be inappropriate for this human application test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| UPCR(Urine Protein/Creatinine Ratio) | — |
Secondary
| Measure | Time frame |
|---|---|
| Glomerular Filtration Rate(eGFR);UACR(Urine Albumin/Creatinine Ratio);Blood Urea Nitrogen;p-cresol(sulfate), Indoxyl sulfate in blood;Trimethylamine N–Oxide in blood;IL-5, IL-6, IL-10, IL-1ß, TNF-a, CRP in blood;Kidney Injury Molecule-1 in urine;NGAL(Neutrophil Gelatinase-Associated Lipocalin) in blood and urine;Fecal flora | — |
Countries
Korea, Republic of
Contacts
Public ContactMihyun Yu
Yonsei University Health System, Severance Hospital
Outcome results
None listed