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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006608
Receipt No. R000001530
Scientific Title Circadian rhythm of serum electrolyte concentrations in renal failure patient
Date of disclosure of the study information 2011/10/28
Last modified on 2012/04/25

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Basic information
Public title Circadian rhythm of serum electrolyte concentrations in renal failure patient
Acronym Circadian rhythm of serum electrolyte concentrations in renal failure patients
Scientific Title Circadian rhythm of serum electrolyte concentrations in renal failure patient
Scientific Title:Acronym Circadian rhythm of serum electrolyte concentrations in renal failure patients
Region
Japan

Condition
Condition chronic renal failure
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine diurnal rhythm of serum electrolyte concentrations are altered by various complications in renal failure patients
Basic objectives2 Others
Basic objectives -Others To determine diurnal rhythm of serum electrolyte concentrations are altered by various complications in renal failure patients
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes circadian rhythm of serum electrolyte (Na, K, Ca, P) concentrations
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 serial mesurement of serum Na, K,Ca, P concentrations
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
20 years-old <=
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria Maintenance hemodialysis at Tsukuba Univ. Hospital or Moka Hospital
Intact PTH concentration less than 100 pg/ml
Patients who are not permitted oral intake and performed intravenous hyper elimentation
Patients who gave informed consent
Key exclusion criteria 1. Patients who treated as secondary hyperparathyriodism
2.Severe anemia (Hb<8mg/dl)
3. Severe liver dysfunction
4.Pregnant women
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kunihiro Yamagata
Organization University of Tsukuba
Division name Department of Nepgrology,
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL 029-853-3202
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shuichi Tsuruoka
Organization University of Tsukuba
Division name Department of Nepgrology
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL 029-853-3202
Homepage URL
Email

Sponsor
Institute Department of Nepgrology,University of Tsukuba
Institute
Department

Funding Source
Organization Department of Nepgrology,University of Tsukuba
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 筑波大学附属病院(茨城県)、真岡病院(栃木県)

Other administrative information
Date of disclosure of the study information
2011 Year 10 Month 28 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 Completed
Date of protocol fixation
2011 Year 02 Month 10 Day
Date of IRB
Anticipated trial start date
2011 Year 11 Month 01 Day
Last follow-up date
2012 Year 04 Month 01 Day
Date of closure to data entry
2012 Year 04 Month 01 Day
Date trial data considered complete
2012 Year 05 Month 01 Day
Date analysis concluded
2012 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 10 Month 25 Day
Last modified on
2012 Year 04 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001530

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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