UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025141 |
|---|---|
| Receipt number | R000028913 |
| Scientific Title | The effect of protein restricted diet on patients with chronic kidney disease on suppression of renal function reduction |
| Date of disclosure of the study information | 2016/12/06 |
| Last modified on | 2022/12/10 15:44:42 |
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Basic information
Public title
The effect of protein restricted diet on patients with chronic kidney disease on suppression of renal function reduction
Acronym
The effect of protein restricted diet on patients with chronic kidney disease on suppression of renal function reduction
Scientific Title
The effect of protein restricted diet on patients with chronic kidney disease on suppression of renal function reduction
Scientific Title:Acronym
The effect of protein restricted diet on patients with chronic kidney disease on suppression of renal function reduction
Region
| Japan |
Condition
Condition
non-dialysis chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine adequate protein intake in chronic kidney disease (CKD).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
nutrient ingestion amount
(at registration, 3 months, 6 months, 12 months, 24 months)
Key secondary outcomes
Serum creatinine
eGFR
BUN
Hb
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)education by a registered dietitian
2)obtain written informed consent
3)eGFR<45ml/min/1.73mm2
(CKD stage 3a, 3b, 4 and 5)
4)non-peritoneal dialysis and non-hemodialysis
Key exclusion criteria
patients who are administering corticosteroids
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiko |
| Middle name | |
| Last name | Kanno |
Organization
Tokyo Medical University
Division name
Division of Nephrology
Zip code
160-0023
Address
6-7-1 Nishishinjyuku,Shinjyuku-ku,Tokyo
TEL
03-3342-6111
kannoyh@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Yukie |
| Middle name | |
| Last name | Kitajima |
Organization
Tokyo Healthcare University
Division name
Division of Medical Nutrition
Zip code
154-8568
Address
3-11-3 Setagaya, Setagaya-ku, Tokyo
TEL
03-5799-3711
Homepage URL
y-kitajima@thcu.ac.jp
Sponsor or person
Institute
The Japanese Society of Renal Nutrition and Metabolism
Institute
Department
Personal name
Funding Source
Organization
The Japanese Society of Renal Nutrition and Metabolism
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
The Japanese Society of Renal Nutrition and Metabolism
Address
4-1-5-6, Hongou, Bunkyo-ku, Tokyo
Tel
03-6801-8084
kannoyh@tokyo-med.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
| 2016 | Year | 12 | Month | 06 | 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
64
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Analyzing
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
| 2016 | Year | 06 | Month | 29 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
There is no other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 05 | Day |
Last modified on
| 2022 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028913
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
