UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009315 |
|---|---|
| Receipt number | R000010941 |
| Scientific Title | The effect of renal phosphate clearance on serum fibroblats growth factor 23 (FGF23) in patients on peritonela dialysis |
| Date of disclosure of the study information | 2012/11/13 |
| Last modified on | 2013/11/15 13:02:49 |
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Basic information
Public title
The effect of renal phosphate clearance on serum fibroblats growth factor 23 (FGF23) in patients on peritonela dialysis
Acronym
The effect of renal phosphate clearance on serum fibroblats growth factor 23 (FGF23) in patients on peritonela dialysis
Scientific Title
The effect of renal phosphate clearance on serum fibroblats growth factor 23 (FGF23) in patients on peritonela dialysis
Scientific Title:Acronym
The effect of renal phosphate clearance on serum fibroblats growth factor 23 (FGF23) in patients on peritonela dialysis
Region
| Japan |
Condition
Condition
Endstage renal disease
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of renal phosphate clearance on serum FGF23 level in patients on peritoneal dialysis
Basic objectives2
Others
Basic objectives -Others
to determine the factors that influence serum FGF23 level in patients on peritoneal dialysis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum fibrobast growth factor 23 (FGF23) concentration
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients on peritoneal dialysis at Kyushu University Hospital who received serum FGF23 determination between June 2010 and June 2012
Key exclusion criteria
Patients who did receive peritoneal dialysis thearapy more than 30 days
Target sample size
60
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, Graduate School of Medical Sciences,
Zip code
Address
3-1-1Maidashi, Higashi-Ku, Fukuoka
TEL
092-642-5843
ana65641@nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shunsuke Yamada |
Organization
Kyushu University
Division name
Department of Integrated Therapy for Chronic Kidney Disease, Graduate School of Medical Sciences
Zip code
Address
Maidashi3-1-1, Higashi-Ku, Fuuoka
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
Other
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
| 2012 | Year | 11 | Month | 13 | 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
Serum levels of FGF23 was negatively associated with residual renal function in patients on peritoneal dialysis, after adjusted for the potential confounders.
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
| 2012 | Year | 11 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 13 | Day |
Last follow-up date
| 2013 | Year | 11 | Month | 15 | Day |
Date of closure to data entry
| 2013 | Year | 11 | Month | 15 | Day |
Date trial data considered complete
| 2013 | Year | 11 | Month | 15 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 31 | Day |
Other
Other related information
We investigate the linear relationship between renal phosphate clearance and serum FGF23 level. We also determine its relationship after adjusting potential confounders. We gather data on clinical and biochemical parameters of blood, urine, and dialysate.
Management information
Registered date
| 2012 | Year | 11 | Month | 12 | Day |
Last modified on
| 2013 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010941
| 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 |
