UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012314 |
|---|---|
| Receipt number | R000014400 |
| Scientific Title | The effect of FGF23 on the regulation of urinarpy phospahte excretion in patients on peritoneal dialysis with decreased residual renal function |
| Date of disclosure of the study information | 2013/11/25 |
| Last modified on | 2014/05/15 13:39:29 |
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Basic information
Public title
The effect of FGF23 on the regulation of urinarpy phospahte excretion in patients on peritoneal dialysis with decreased residual renal function
Acronym
The effect of FGF23 on the regulation of urinary phosphate excretion in decreased residual renal function status
Scientific Title
The effect of FGF23 on the regulation of urinarpy phospahte excretion in patients on peritoneal dialysis with decreased residual renal function
Scientific Title:Acronym
The effect of FGF23 on the regulation of urinary phosphate excretion in decreased residual renal function status
Region
| Japan |
Condition
Condition
Endstage kidney disease
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of increased fibroblast growth factor 23 (FGF23) on the urinary phospahte excretion in patients on peritoneal dialysis
Basic objectives2
Others
Basic objectives -Others
To investigate the association between serum FGF23 level and urinary phosphate excretion
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
daily urinary phosphtae excretion
Key secondary outcomes
TmP/GFR
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
outpatients on peritoneal dialysis who recieved regular follow-up at Kyuhsu University Hospital
Key exclusion criteria
patients who did not collect 24-hr collection of urine and peritoneal dialysate
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Tsuruya |
Organization
Kyushu University
Division name
Department of Integrated Therapy for Chronic Kidney Disease
Zip code
Address
Maidashi3-1-1, Higasi-Ku, Fukuoka
TEL
092-642-5845
tsuruya@intmed2.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shunsuke Yamada |
Organization
Kyushu University Hospital
Division name
Kidney Care Unit
Zip code
Address
Maidashi3-1-1, Higasi-Ku, Fukuoka
TEL
092-642-5843
Homepage URL
ana65641@nifty.com
Sponsor or person
Institute
Department of Integrated Therapy for Chronic Kidney Disease, Graduate School of Medical Sciences, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Department of Integrated Therapy for Chronic Kidney Disease, Graduate School of Medical Sciences, Kyushu University
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
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
| 2013 | Year | 11 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2013 | Year | 11 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 05 | Month | 15 | Day |
Other
Other related information
In the present study, we gather demographci data, biochemical parameters, medication, and data on collected urine and dialysate. Serum FGF23 level was determined by the use of frozen serum sample. Multivariabel analysese wil be perfromed to determine the association between urinary phosphate excretion and redisual renal function, after adjusted for the potentila confounders. This study is the subanalysis of the pre-registered observational study.
Management information
Registered date
| 2013 | Year | 11 | Month | 15 | Day |
Last modified on
| 2014 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014400
| Research Plan | |
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| 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 |
