Chronic Kidney Disease Stage 5NCT05350098
Efficacy of Plant-protein Diets in Patients With Chronic Kidney Disease
A study testing Plant-protein Diets in people with Chronic Kidney Disease Stage 5, run by Osaka University at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the efficacy of plant-protein diets for 12 weeks in patients with advanced chronic kidney disease. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Kidney Disease Stage 5
- What is being tested?
- Plant-protein Diets
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteJapan
- Study dates
- 1 Jan 2023to 30 Mar 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with chronic kidney disease who were referred to the Outpatient Department of Nephrology at Osaka University Hospital
- eGFR < 20 mL/min/1.73 m2
- taking anigiotensin-converting enzyme inhibitors or angiotensin Ⅱ receptor blockers or angiotensin receptor neprilysin inhibitor
- K < 5.5 mEq/L
Who cannot join
- Being planned to intitate renal replacement therapies within 3 months
- Having inflammatory bowel diseases
- History of gastrointestinal tract surgery
- Taking antibiotics within 1 month before the entry
- Taking or being planned to start warfarin
- Having dietary allergies
Show all 9Show fewer
- Having difficulty in oral intake
- During pregnancy or breastfeeding
- Unsuitable for participant in the trial by an attending physician
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial to Evaluate the Efficacy of Plant-protein Diets in Patients With Chronic Kidney Disease: a Pilot-study
The purpose of this study is to evaluate the efficacy of plant-protein diets for 12 weeks in patients with advanced chronic kidney disease.
- Conditions
- Chronic Kidney Disease Stage 5
- Being tested
- Plant-protein Diets, Control Diets
- Keywords
- plant-protein diets, chronic kidney disease, uremic solutes, metabolic acidosis, chronic kidney disease-mineral and bone disorder, gut microbiome
- Medical subject headings
- Renal Insufficiency, Chronic, Acidosis, Chronic Kidney Disease-Mineral and Bone Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant-protein DietsOther
Participants will consume meals with 70% plant-based protein three times a day. Participants will be prohibited to have meals other than experimental diets and to drink milk and soy milk.
Control DietsOther
Participants will consume meals with 50% plant-based protein three times a day. Participants will be prohibited to have meals other than experimental diets and to drink milk and soy milk.
| Study group | Role | What they receive |
|---|---|---|
| A dietary intervention of plant-protein based diets | Experimental | Not described Receives: Other: Plant-protein Diets |
| A dietary intervention of control diets | Active comparator | Not described Receives: Other: Control Diets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum levels of indoxyl sulfate, p-Cresyl sulfate and trimethylamine N-Oxide
Measured: 4 weeks after starting intervention
Secondary outcomes (11)
Change in eGFR
Measured: 4 weeks after starting intervention
Change in urinary protein creatinine ratio
Measured: 4 weeks after starting intervention
Change in serum bicarbonete levels
Measured: 4 weeks after starting intervention
Change in urinary citrate to creatinine ratio
The measurement of this outcome was abandoned because of the end of sales for its measuring reagent (F-kit citrate; JK International, Tokyo, Japan) in Japan on December 23, 2022. This decision had been made before we initiatited the recruitement of study participants.
Measured: 4 weeks after starting intervention
Change in blood pressure
Measured: 4 weeks after starting intervention
Change in serum levels of calcium, phosphate, intact parathyroid hormone and intact fibroblast growth factor 23
Measured: 4 weeks after starting intervention
Change in serum levels of acetic acid, propionic acid and butyric acid
Measured: 4 weeks after starting intervention
Diversity and composition of the gut microbiota
Measured: 4 weeks after starting intervention
Change in muscle mass
Measured: 4 weeks after starting intervention
Dietary adherence
How many times participants have the study diet during the study period.
Measured: 4 weeks after starting intervention
The number of oral medications including antihypertensive drugs, diuretics, potassium tablets, potassium binders, phosphate binders, calcium tablets, active vitamin D3 analogs and sodium bicarbonate
Measured: 4 weeks after starting intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start1 Jan 2023
- Primary completion30 Mar 2024
- Study completion30 Mar 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 5Studies 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
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osaka University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yusuke Sakaguchi, Osaka University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05350098
- Sponsor's protocol ID
- 21371
- Status last verified
- Oct 2026
- First submitted
- 6 Apr 2022
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Uwatoko R, Sakaguchi Y, Oka T, Doi Y, Kawano Y, Kadono H, Fukuda S, Yamamoto R, Matsui I, Mizui M, Kaimori JY, Isaka Y. Normoproteic Plant-Dominant Protein Diets, Uremic Toxins, and Gut Microbiota in Patients With Advanced CKD: A Randomized Controlled Trial. Am J Kidney Dis. 2026 Sep 21:S0272-6386(26)01119-4. doi: 10.1053/j.ajkd.2026.07.008. Online ahead of print.
PubMed 42767319
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Evaluate the Efficacy of Plant-protein Diets in Patients With Chronic Kidney Disease: a Pilot-study
- ClinicalTrials.gov ID
- NCT05350098
- Acronym / sponsor ID
- 21371
- Conditions
- Chronic Kidney Disease Stage 5
- Keywords
- plant-protein diets, chronic kidney disease, uremic solutes, metabolic acidosis, chronic kidney disease-mineral and bone disorder, gut microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Osaka UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 27 Apr 2022 (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.
The purpose of this study is to evaluate the efficacy of plant-protein diets for 12 weeks in patients with advanced chronic kidney disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A dietary intervention of plant-protein based diets | Experimental | Other: Plant-protein Diets |
| A dietary intervention of control diets | Active comparator | Other: Control Diets |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with chronic kidney disease who were referred to the Outpatient Department of Nephrology at Osaka University Hospital
- eGFR < 20 mL/min/1.73 m2
- taking anigiotensin-converting enzyme inhibitors or angiotensin Ⅱ receptor blockers or angiotensin receptor neprilysin inhibitor
- K < 5.5 mEq/L
Key exclusion criteria (9 listed)
- Being planned to intitate renal replacement therapies within 3 months
- Having inflammatory bowel diseases
- History of gastrointestinal tract surgery
- Taking antibiotics within 1 month before the entry
- Taking or being planned to start warfarin
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 |
|---|---|---|
| Plant-protein DietsParticipants will consume meals with 70% plant-based protein three times a day. Participants will be prohibited to have meals other than experimental diets and to drink milk and soy milk. | Other | A dietary intervention of plant-protein based diets |
| Control DietsParticipants will consume meals with 50% plant-based protein three times a day. Participants will be prohibited to have meals other than experimental diets and to drink milk and soy milk. | Other | A dietary intervention of control diets |
Primary outcome
Change in serum levels of indoxyl sulfate, p-Cresyl sulfate and trimethylamine N-Oxide
Time frame: 4 weeks after starting intervention
11 secondary outcomes
Change in eGFR
Time frame: 4 weeks after starting intervention
Change in urinary protein creatinine ratio
Time frame: 4 weeks after starting intervention
Change in serum bicarbonete levels
Time frame: 4 weeks after starting intervention
Change in urinary citrate to creatinine ratio
Time frame: 4 weeks after starting intervention
Change in blood pressure
Time frame: 4 weeks after starting intervention
Change in serum levels of calcium, phosphate, intact parathyroid hormone and intact fibroblast growth factor 23
Time frame: 4 weeks after starting intervention
Change in serum levels of acetic acid, propionic acid and butyric acid
Time frame: 4 weeks after starting intervention
Diversity and composition of the gut microbiota
Time frame: 4 weeks after starting intervention
Change in muscle mass
Time frame: 4 weeks after starting intervention
Dietary adherence
Time frame: 4 weeks after starting intervention
The number of oral medications including antihypertensive drugs, diuretics, potassium tablets, potassium binders, phosphate binders, calcium tablets, active vitamin D3 analogs and sodium bicarbonate
Time frame: 4 weeks after starting intervention
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 16 Oct 2026.
- Derived from this study: PubMed 42767319Uwatoko R, Sakaguchi Y, Oka T, Doi Y, Kawano Y, Kadono H, Fukuda S, Yamamoto R, Matsui I, Mizui M, Kaimori JY, Isaka Y. Normoproteic Plant-Dominant Protein Diets, Uremic Toxins, and Gut Microbiota in Patients With Advanced CKD: A Randomized Controlled Trial. Am J Kidney Dis. 2026 Sep 21:S0272-6386(26)01119-4. doi: 10.1053/j.ajkd.2026.07.008. Online ahead of print.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plant-protein Diets in people with Chronic Kidney Disease Stage 5, run by Osaka University at 1 site in Japan.
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 4 inclusion and 9 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 16 Oct 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 Japan. 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. 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 serum levels of indoxyl sulfate, p-Cresyl sulfate and trimethylamine N-Oxide (time frame: 4 weeks after starting intervention). 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 NCT05350098, 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 16 Oct 2026.