UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006608 |
|---|---|
| Receipt number | 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 12:32:23 |
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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
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
Sponsor or person
Institute
Department of Nepgrology,University of Tsukuba
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001530
