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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033488
Receipt No. 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 2018/07/24

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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
Middle name
Last name Yoshitaka Maeda
Organization JA Toride Medical Center
Division name Nephrology
Zip code
Address 2-1-1 Hongo, Toride, Ibaraki, Japan
TEL 81-297-74-5551
Email yoshimaeda43@toride-medical.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshitaka Maeda
Organization JA Toride Medical Center
Division name Nephrology
Zip code
Address 2-1-1 Hongo, Toride, Ibaraki, Japan
TEL 81-297-74-5551
Homepage URL
Email yoshimaeda43@toride-medical.or.jp

Sponsor
Institute JA Toride Medical Center
Institute
Department

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
Address
Tel
Email

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
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 consulting 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
2018 Year 07 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025496

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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