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

Kefir Peptides Supplement for Inflammation, Oxidative Stress and Lipid Abnormalities in Chronic Kidney Disease Patients

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.

Study Overview

• Status: Completed
• Conditions: Proteinuria; Chronic Kidney Disease Stage 3; Chronic Kidney Disease Stage 4
• Intervention / Treatment: Dietary supplement: KEFPEP®; Dietary supplement: Placebo

Detailed Description

Background and Aim Chronic kidney disease (CKD) represents a substantial global public health burden, with prevalence rising due to population aging and an increased incidence of systemic conditions such as hypertension, diabetes mellitus, metabolic syndrome, and chronic exposure to nephrotoxic agents. Accumulation of uremic toxins in CKD contributes to gut dysbiosis, systemic inflammation, accelerated renal functional decline, and heightened cardiovascular risk.

Probiotics and postbiotics have been evaluated as potential adjunct therapies to slow CKD progression; however, conclusive evidence supporting their clinical effectiveness remains limited. Kefir peptides (KPs) contain bioactive constituents with documented antioxidant, antidiabetic, antithrombotic, antibacterial, anti-osteoporotic, and immunomodulatory properties. Based on these characteristics, KPs may offer therapeutic benefits in modulating renal function, systemic inflammation, and uremic toxin burden in individuals with advanced CKD.

The current investigation aims to examine the effects of kefir peptides on renal function and clinical proteinuria, and to explore possible mechanistic pathways contributing to these outcomes.

Methods A total of 165 participants were enrolled: 83 in the placebo group and 82 in the kefir peptide group. All participants consumed the assigned kefir formulation twice daily for three months. Blood and urine biochemical assessments were conducted at baseline (week 0), week 4, and week 12. Serum high-sensitivity C-reactive protein (hs-CRP), indoxyl sulfate (IS), and p-cresyl sulfate (PCS) levels were measured at baseline and at week 12. All study procedures and monitoring activities were performed by the investigator.

• Study Type: Interventional
• Enrollment (Actual): 165
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 412
    • Jen-Ai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Acute illness
• Pregnancy
• Aboriginal descent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KEFPEP®; Powder (directly take the powder with appropriate amount of warm water)	Dietary supplement: KEFPEP®; oral administration at a daily dosage of 2.4 grams for 12 weeks
Placebo Comparator: Placebo; Powder (directly take the powder with appropriate amount of warm water)	Dietary supplement: Placebo; using regular yogurt powder as a substitute for KPs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in renal function biomarker( BUN & Cr)	Baseline to 12 weeks
Change in urine protein-to-creatinine ratio (UPCR)	Baseline to 12 weeks

Collaborators and Investigators

• Sponsor: National Chung Hsing University
• Collaborators: Jen Ai Hospital
• Investigators: Study Director: YU-HSIEN LIU, Master, Jen Ai Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): August 1, 2024

Study Registration Dates

• First Submitted: November 22, 2025
• First Submitted That Met QC Criteria: November 22, 2025
• First Posted (Estimated): December 3, 2025

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Chronic kidney disease; Proteinuria; Postbiotics; Gut dysbiosis; Kefir peptides,
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Urination Disorders; Urological Manifestations; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Renal Insufficiency, Chronic; Proteinuria
• Other Study ID Numbers: PHP2201H04; 111-89 (Other Grant/Funding Number: Jen-Ai Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared due to concerns regarding patient privacy and confidentiality. Only de-identified and aggregated data will be included in future publications or presentations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No