UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052907 |
|---|---|
| Receipt number | R000060368 |
| Scientific Title | Establishment of ketogenic diet therapy guidance in Japanese patients with ADPKD |
| Date of disclosure of the study information | 2023/11/27 |
| Last modified on | 2023/11/26 21:26:32 |
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Basic information
Public title
Establishment of ketogenic diet therapy guidance in Japanese patients with ADPKD
Acronym
Ketogenic diet therapy in Japanese ADPKD
Scientific Title
Establishment of ketogenic diet therapy guidance in Japanese patients with ADPKD
Scientific Title:Acronym
Ketogenic diet therapy in Japanese ADPKD
Region
| Japan |
Condition
Condition
Autosomal dominant polycystic kidney
Classification by specialty
| Nephrology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will examine the usefulness and tolerability of web-based tools for dietary guidance and nutritional management for patients with autosomal manifest polycystic kidney disease (ADPKD).
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Health status assessment (baseline and 3, 6, 9, and 12 months)
Height, weight, BMI, abdominal circumference, blood pressure
Blood samples (blood count, biochemistry; BUN, Cre, AST, ALT, LDH, ALP, T-Bil, D-Bil, fasting blood sugar, total-LDL-HDL-cholesterol, TG, HbA1c, CRP, adiponectin, leptin, ghrelin)
Urine (specific gravity, PH, protein, ketone bodies, white blood cells, red blood cells, glucose, creatinine, Na, Pi)
Height-adjusted total kidney volume (hTKV) from MRI or other imaging studies (at baseline and 12 months only, not exceeding the range of actual clinical kidney volume measurements)
(Not to exceed the range of actual clinical renal volume measurements at baseline and 12 months only)
Home measurements of blood ketone levels, blood glucose levels, and urinary Ph: daily for 1-12 weeks, weekly thereafter.
Only these three items will be collected at home. Only these three items will be collected at home, and the others at the hospital.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Change diet to a plant-based ketogenic diet
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Male or female, 18 years of age or older
(2) Have a confirmed diagnosis of ADPKD based on ADPKD guidelines
(3) Estimated glomerular filtration rate (eGFR) >30 mL/min/1.73 m2 at screening (according to [CKD-EPI] formula)
(4) Female participants are not pregnant or lactating or planning to become pregnant or lactating during the study period
(5) Able to read, understand, and respond to the survey form
(6) Have no problems with the web environment and are able to take online classes. Also, able to complete the form online
(7) Have voluntary written consent to participate in the study
Key exclusion criteria
(1) poorly controlled diabetes mellitus with HbA1C > 8.0
(2) Uncontrolled dyslipidemia with LDL cholesterol > 4 mmol/L or triglycerides > 3 mmol/L
(3) Uncontrolled hypertension (SBP > 160 and/or BP > 100 mm Hg on 3 occasions)
(5) Hyperkalemia (>5.5 mmol/l).
(6) Significant disease such as malignancy within the past 5 years, autoimmune disease under immunosuppressive treatment
(8) On any medication (SGLT2 inhibitor) or investigational drug that may affect the safety of the ketogenic diet (since bardoxolone methyl for ADPKD is under investigation in Japan).
(12) Food sensitivities or allergies incompatible with the nutritional program
(13) Subject is already compliant with a ketogenic diet or fasting
(14) Current or past history of eating disorders or eating behaviors
(16) Ulcerative colitis, irritable bowel syndrome, Crohn's disease, or gallbladder disease
(17) BMI less than 18
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shigeo |
| Middle name | |
| Last name | Horie |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Urology
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
0338133111
harunase@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Haruna |
| Middle name | |
| Last name | Kawano |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Urology
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
0338133111
Homepage URL
harunase@juntendo.ac.jp
Sponsor or person
Institute
Department of Urology, Juntendo University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Urology, Juntendo University Graduate School of Medicine
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
Juntendo University Graduate School of Medicine
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan
Tel
0338133111
hongo-rinri@juntendo.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
| 2023 | Year | 11 | Month | 27 | 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
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
Preinitiation
Date of protocol fixation
| 2023 | Year | 09 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 26 | Day |
Last modified on
| 2023 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060368
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