UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033488 |
|---|---|
| Receipt number | R000025496 |
| Scientific Title | Urinary phosphorus excretion per creatinine clearance as a possible risk factore for renal survival |
| Date of disclosure of the study information | 2018/07/24 |
| Last modified on | 2021/07/26 14:37:43 |
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Basic information
Public title
Urinary phosphorus excretion per creatinine clearance as a possible risk factore for renal survival
Acronym
UP/Ccr as a risk factor for renal survival
Scientific Title
Urinary phosphorus excretion per creatinine clearance as a possible risk factore for renal survival
Scientific Title:Acronym
UP/Ccr as a risk factor for renal survival
Region
| Japan |
Condition
Condition
stage 3, 4, and 5 of chronic kidney disease (CKD)
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Urinary phosphorus excretion per creatinine clearance (UP/Ccr) will be examined to be a possible prognostic marker for CKD progression.
Basic objectives2
Others
Basic objectives -Others
UP/Ccr in spot urine samples will be examined to be a surrogate marker of UP/Ccr in collected urine samples
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The association of UP/Ccr in collected urine samples and CKD progression will be studied in five years after registration
Key secondary outcomes
The association of UP/Ccr in collected urine samples and kidney death and patient's death will be studied in five years after registration
Diffrences and similarities of UP/Ccr between spot and collected urine samples
Base
Study type
Observational
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
| 15 | years-old | <= |
Age-upper limit
| 110 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Chronic kidney disease patients
Key exclusion criteria
None
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Maeda |
Organization
JA Toride Medical Center
Division name
Nephrology
Zip code
302-0022
Address
2-1-1 Hongo, Toride, Ibaraki, Japan
TEL
81-297-74-5551
yoshimaeda43@toride-medical.or.jp
Public contact
Name of contact person
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Maeda |
Organization
JA Toride Medical Center
Division name
Nephrology
Zip code
302-0022
Address
2-1-1 Hongo, Toride, Ibaraki, Japan
TEL
81-297-74-5551
Homepage URL
yoshimaeda43@toride-medical.or.jp
Sponsor or person
Institute
JA Toride Medical Center
Institute
Department
Personal name
Funding Source
Organization
JA Toride Medical 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
Ethical Committee of JA Toride Medical Center
Address
2-1-1 Hongo, Toride, Ibaraki, Japan
Tel
81-297-74-5551
yoshimaeda43@toride-medical.or.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
| 2018 | Year | 07 | Month | 24 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 29 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2027 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2027 | Year | 12 | Month | 31 | Day |
Other
Other related information
Patients who consult Nephrology division of JA Toride Medical Center will be enrolled in this study, after obtaining their informed consents.
Management information
Registered date
| 2018 | Year | 07 | Month | 24 | Day |
Last modified on
| 2021 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025496
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
