UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050234 |
|---|---|
| Receipt number | R000056133 |
| Scientific Title | Randomized controlled trial on the safety of protein restriction in patients with conservative chronic kidney disease patients |
| Date of disclosure of the study information | 2023/02/05 |
| Last modified on | 2023/02/04 07:30:50 |
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Basic information
Public title
Randomized controlled trial on the safety of protein restriction in patients with conservative chronic kidney disease patients
Acronym
Randomized controlled trial on the safety of protein restriction in patients with conservative chronic kidney disease patients
Scientific Title
Randomized controlled trial on the safety of protein restriction in patients with conservative chronic kidney disease patients
Scientific Title:Acronym
Randomized controlled trial on the safety of protein restriction in patients with conservative chronic kidney disease patients
Region
| Japan |
Condition
Condition
conservative chronic kidney disease patients
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine that the protein-restricted group does not result in muscle mass loss or muscle weakness compared to the non-protein-restricted group.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change from baseline in skeletal muscle mass index at 1 year
Key secondary outcomes
Change from baseline in grip strength, SPBB, eGFR, and urinary protein at 1 year
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
If assigned to the protein-restricted group, nutritional guidance will be given with the following goals: patients with eGFR 44 ml/min/1.73 m2 or less will be protein restricted with a target protein intake of 0.7-0.8 g/kg (BW)/day; patients with eGFR 45-59 ml/min/1.73 m2 or less will be protein restricted with a target protein intake of 0.8-1.0 g/kg (BW)/day. Ideal body weight (height(m)*height(m)*22) should be used.
Interventions/Control_2
If assigned to the no protein restriction group, protein restriction will not be taught, but if protein intake exceeds 1.5 g/kg/day in urine storage, protein intake of 1.3 g/kg/day or less will be taught.
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
| 50 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are at least 50 years of age and have given written consent to participate in the study
Key exclusion criteria
Patients who are expected to receive renal replacement therapy within one year
Patients with urinary protein >3.5 g/gCr
Patients on steroids or expected to be on steroids
Patients with pacemakers or ICDs
Patients who the investigator determines to be inappropriate as research subjects
Target sample size
190
Research contact person
Name of lead principal investigator
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Hashimoto |
Organization
Osaka General Medhical Center
Division name
Kidney disesase and Hypertention
Zip code
5588558
Address
3-1-56 mandaihigashi, Osaka 558-8558, Japan
TEL
0666921201
kyuseisogo@opho.jp
Public contact
Name of contact person
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Hashimoto |
Organization
Osaka General Medhical Center
Division name
Kidney disesase and Hypertention
Zip code
5588558
Address
3-1-56 mandaihigashi, Osaka 558-8558, Japan
TEL
0666921201
Homepage URL
kyuseisogo@opho.jp
Sponsor or person
Institute
Osaka General Medhical Center Kidney disesase and Hypertention
Institute
Department
Personal name
Funding Source
Organization
Osaka General Medhical Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka General Medhical Center
Address
3-1-56 mandaihigashi, Osaka 558-8558, Japan
Tel
0666921201
kyuseisogo@opho.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 | 02 | Month | 05 | 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
| 2022 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2023 | Year | 02 | Month | 04 | Day |
Last modified on
| 2023 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056133
