Chronic Kidney Disease Stage 3KPs; CKDNCT07260292
KPs Supplement for Inflammation, Oxidative Stress and Lipid Abnormalities in CKD Patients.
A study testing KEFPEP® in people with Chronic Kidney Disease Stage 3 and Chronic Kidney Disease Stage 4, run by National Chung Hsing University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 82 years
- Conditions the study is for
- Chronic Kidney Disease Stage 3, Chronic Kidney Disease Stage 4, Proteinuria
- What is being tested?
- KEFPEP®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Feb 2023to 2 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 82 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 30-82 years of age
- Chronic kidney disease stage 3 and 4
- Sign informed consent
Who cannot join
- Acute illness
- Pregnancy
- Aboriginal descent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- KEFPEP®, Placebo
- Keywords
- Chronic kidney disease, Gut dysbiosis, Proteinuria, Kefir peptides,, Postbiotics
- Medical subject headings
- Renal Insufficiency, Chronic, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KEFPEP®Dietary supplement
oral administration at a daily dosage of 2.4 grams for 12 weeks
PlaceboDietary supplement
using regular yogurt powder as a substitute for KPs
| Study group | Role | What they receive |
|---|---|---|
| KEFPEP® | Experimental | Powder (directly take the powder with appropriate amount of warm water) Receives: Dietary Supplement: KEFPEP® |
| Placebo | Placebo comparator | Powder (directly take the powder with appropriate amount of warm water) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in renal function biomarker( BUN & Cr)
Measured: Baseline to 12 weeks
Change in urine protein-to-creatinine ratio (UPCR)
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start3 Feb 2023
- Primary completion30 Dec 2023
- Study completion2 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease Stage 3Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, double-blind, placebo-controlled, parallel study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Chung Hsing University
- Sponsor type
- University, hospital or other
- Collaborators
- Jen Ai Hospital
- Responsible party
- Principal investigator, Chuan -Mu Chen, National Chung Hsing University
- Investigators
- YU-HSIEN LIU, Master, Study director, Jen Ai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07260292
- Sponsor's protocol ID
- PHP2201H04
- Other IDs
- 111-89
- Acronym
- KPs; CKD
- Status last verified
- Apr 2025
- First submitted
- 22 Nov 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 35740095
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kefir Peptides Supplement for Inflammation, Oxidative Stress and Lipid Abnormalities in Chronic Kidney Disease Patients
- ClinicalTrials.gov ID
- NCT07260292
- Acronym / sponsor ID
- KPs; CKD / PHP2201H04
- Keywords
- Chronic kidney disease, Gut dysbiosis, Proteinuria, Kefir peptides,, Postbiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- National Chung Hsing UniversityUniversity, hospital or other
- Collaborators
- Jen Ai Hospital
- Study start
- 3 Feb 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 2 Aug 2024 (actual)
- First posted
- 3 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, double-blind, placebo-controlled, parallel study
| Arm | Type | Receives |
|---|---|---|
| KEFPEP® | Experimental | Dietary Supplement: KEFPEP®Powder (directly take the powder with appropriate amount of warm water) |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPowder (directly take the powder with appropriate amount of warm water) |
Who may qualify
- Ages
- 30 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: 30-82 years of age
- Chronic kidney disease stage 3 and 4
- Sign informed consent
Key exclusion criteria (3 listed)
- Acute illness
- Pregnancy
- Aboriginal descent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KEFPEP®oral administration at a daily dosage of 2.4 grams for 12 weeks | Dietary supplement | KEFPEP® |
| Placebousing regular yogurt powder as a substitute for KPs | Dietary supplement | Placebo |
Primary outcome
Change in renal function biomarker( BUN & Cr)
Time frame: Baseline to 12 weeks
Change in urine protein-to-creatinine ratio (UPCR)
Time frame: Baseline to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Background: PubMed 35740095Liu 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
YU-HSIEN LIU, Master study director
Jen Ai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KEFPEP® in people with Chronic Kidney Disease Stage 3 and Chronic Kidney Disease Stage 4, run by National Chung Hsing University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in renal function biomarker( BUN & Cr) (time frame: Baseline to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07260292, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.