KPs Supplement for Inflammation, Oxidative Stress and Lipid Abnormalities in CKD Patients.

NCT07260292 | Completed

• 2 other identifiers: PHP2201H04111-89
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical investigation is designed to evaluate the potential therapeutic effects of kefir peptides as an adjunct intervention for chronic kidney disease (CKD) and clinical proteinuria. Patients diagnosed with stage 3 or 4 CKD will receive a three-month course of kefir peptide supplementation. Throughout the intervention period, the investigator will monitor renal function markers (blood urea nitrogen, serum creatinine), proteinuria (urine protein-to-creatinine ratio), inflammatory indicators (high-sensitivity C-reactive protein), and additional biochemical parameters relevant to CKD progression.

Conditions

Chronic Kidney Disease Stage 3; Chronic Kidney Disease Stage 4; Proteinuria

Keywords

Chronic kidney disease; Gut dysbiosis; Proteinuria; Kefir peptides,; Postbiotics

Outcome Measures

Primary Outcomes (2)

• Change in renal function biomarker( BUN & Cr)

  Baseline to 12 weeks

• Change in urine protein-to-creatinine ratio (UPCR)

  Baseline to 12 weeks

Study Arms (2)

KEFPEP®

EXPERIMENTAL

Powder (directly take the powder with appropriate amount of warm water)

Dietary Supplement: KEFPEP®

Placebo

PLACEBO COMPARATOR

Powder (directly take the powder with appropriate amount of warm water)

Dietary Supplement: Placebo

Interventions

KEFPEP® DIETARY_SUPPLEMENT

oral administration at a daily dosage of 2.4 grams for 12 weeks

KEFPEP®

Placebo DIETARY_SUPPLEMENT

using regular yogurt powder as a substitute for KPs

Placebo

Eligibility Criteria

• Age: 30 Years - 82 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 30-82 years of age
• Chronic kidney disease stage 3 and 4
• Sign informed consent

You may not qualify if:

• Acute illness
• Pregnancy
• Aboriginal descent

Sponsors & Collaborators

• National Chung Hsing University: lead
• Jen Ai Hospital: collaborator

Study Sites (1)

Jen-Ai Hospital

Taichung, 412, Taiwan

Location

Related Publications (1)

• Liu YH, Chen YH, Ko CH, Kuo CW, Yen CC, Chen W, Chong KY, Chen CM. SOD3 and IL-18 Predict the First Kidney Disease-Related Hospitalization or Death during the One-Year Follow-Up Period in Patients with End-Stage Renal Disease. Antioxidants (Basel). 2022 Jun 18;11(6):1198. doi: 10.3390/antiox11061198.

  PMID: 35740095 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Proteinuria

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urological Manifestations; Signs and Symptoms

Study Officials

• YU-HSIEN LIU, Master

  Jen Ai Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants and investigators were unaware of group assignment; placebo was identical in appearance to study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair Professor

Model Details: This is a randomized, double-blind, placebo-controlled, parallel study

Study Record Dates

• First Submitted: November 22, 2025
• First Posted: December 3, 2025
• Study Start: August 1, 2023
• Primary Completion: December 30, 2023
• Study Completion: August 1, 2024
• Last Updated: December 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)