UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047150 |
|---|---|
| Receipt number | R000053786 |
| Scientific Title | A Randomized Controlled Trial to Evaluate the Efficacy of plant-protein diets in Patients with Chronic Kidney Disease: a pilot-study |
| Date of disclosure of the study information | 2022/03/11 |
| Last modified on | 2023/09/11 12:34:20 |
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Basic information
Public title
A Randomized Controlled Trial to Evaluate the Efficacy of plant-protein diets in Patients with Chronic Kidney Disease: a pilot-study
Acronym
A Randomized Controlled Trial to Evaluate the Efficacy of plant-protein diets in Patients with Chronic Kidney Disease: a pilot-study
Scientific Title
A Randomized Controlled Trial to Evaluate the Efficacy of plant-protein diets in Patients with Chronic Kidney Disease: a pilot-study
Scientific Title:Acronym
A Randomized Controlled Trial to Evaluate the Efficacy of plant-protein diets in Patients with Chronic Kidney Disease: a pilot-study
Region
| Japan |
Condition
Condition
chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the efficacy of plant-protein diets for 4 weeks in patients with advanced chronic kidney disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in serum levels of indoxyl sulfate, p-Cresyl sulfate and trimethylamine N-Oxide
Key secondary outcomes
1) Change in eGFR and urinary protein creatinine ratio
2) Change in serum bicarbonate levels
3) Change in systolic and diastolic blood pressure
4) Change in serum levels of calcium, phosphate, intact parathyroid hormone and intact fibroblast growth factor 23
5) Change in serum levels of acetic acid, propionic acid and butyric acid
6) Change in gut microbiome composition
7) Change in muscle strength
8) Dietary adherence
9) Oral medications including antihypertensive drugs, diuretics, potassium tablets, potassium binders, phosphate binders, calcium tablets, active vitamin D3 analogs and sodium bicarbonate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
plant-protein diets
Interventions/Control_2
control diets
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with chronic kidney disease who were referred to the Outpatient Department of Nephrology at Osaka University Hospital
2) eGFR < 20 mL/min/1.73 m2
3) Taking anigiotensin-converting enzyme inhibitors or angiotensin II receptor blockers or angiotensin receptor neprilysin inhibitor
4) K < 5.5 mEq/L
Key exclusion criteria
1) Being planned to intitate renal replacement therapies within 3 months
2) Having inflammatory bowel diseases
3) History of gastrointestinal tract surgery
4) Taking antibiotics within 1 month before the entry
5) Taking or being planned to start warfarin
6) Having dietary allergies
7) Having difficulty in oral intake
8) During pregnancy or breastfeeding
9) Unsuitable for participant in the trial by an attending physician
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Sakaguchi |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Inter-Organ Communication Research in Kidney Diseases
Zip code
565-0871
Address
2-2, Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3747
sakaguchi@kid.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Sakaguchi |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Inter-Organ Communication Research in Kidney Diseases
Zip code
565-0871
Address
2-2, Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3747
Homepage URL
sakaguchi@kid.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Clinical Research Review Committee
Address
2-2, Yamadaoka, Suita, Osaka, Japan
Tel
06-6210-8296
rinri@hp-crc.med.osaka-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
40
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2021 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 11 | Day |
Last modified on
| 2023 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053786
