UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019095 |
|---|---|
| Receipt number | R000022066 |
| Scientific Title | Association between changes in serum level of fibroblast growth factor 23 and treatment in patients undergoing peritoneal dialysis |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2016/07/02 16:24:05 |
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Basic information
Public title
Association between changes in serum level of fibroblast growth factor 23 and treatment in patients undergoing peritoneal dialysis
Acronym
Association between changes in serum level of fibroblast growth factor 23 and treatment in patients undergoing peritoneal dialysis
Scientific Title
Association between changes in serum level of fibroblast growth factor 23 and treatment in patients undergoing peritoneal dialysis
Scientific Title:Acronym
Association between changes in serum level of fibroblast growth factor 23 and treatment in patients undergoing peritoneal dialysis
Region
| Japan |
Condition
Condition
Endstage Kidney Disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the association between changes in serum FGF23 level and treatment in patients undergoing peritoneal dialysis
Basic objectives2
Others
Basic objectives -Others
This is a retrospective study to determine the factors that are associated with the changes in serum FGF23 level in patients undergoing peritoneal dialysis. Among the patients who were registered to Fukuoka Peritoneal Dialysis Registry in December 2011, patients who received frozen serum collection at Kyushu University are recruited in the present study. We measures serum fibroblast growth factor 23 level using the frozen sera at baseline and at 18 month by commercially available ELISA kits. We also record clinical information related to peritoneal dialysis from the medical records. Clinical information includes age, sex, dialysis vintage, underlying kidney disease, serum biochemical parameters (calcium, phosphate, parathyroid hormone, albumin, urea nitrogen, creatinine), renal and peritoneal creatinine clearance, renal and peritoneal urea clearance, and use of medications (phosphate binder, vitamin D receptor activator, cinacalcet, and glucocorticoid).
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in serum fibroblast growth factor 23 level
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients 1) who were registered to Fukuoka Peritoneal Dialysis Registry, 2) received peritoneal dialysis at Kyushu University, and 3) had frozen serum at baseline and at 18 month
Key exclusion criteria
Patients who recieved both hemodialysis and peritoneal dialysis therapy
Target sample size
50
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
3-1-1 Maidashi, Higashi-Ku, Fukuoka, Japan
TEL
092-642-5843
tsuruya@intmed2.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shunsuke Yamada |
Organization
Kyushu University
Division name
Department of Medicine and Clinical Science
Zip code
Address
3-1-1 Maidashi, Higashi-Ku, Fukuoka, Japan
TEL
092-642-5843
Homepage URL
ana65641@nifty.com
Sponsor or person
Institute
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
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
26-223
Org. issuing International ID_1
Activities of Center for Clinical and Translational Research, of Kyushu University Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 01 | 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
In the multivariable analysis, a lower total phosphate elimination and use of vitamin D receptor activators at baseline were positively associated with the increase in serum FGF23 level, whereas use of cinacacet at baseline was negatively associated with the increase in serum FGF23 level in patients who undergo peritoneal dialysis.
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
| 2015 | Year | 05 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 23 | Day |
Last follow-up date
| 2015 | Year | 10 | Month | 12 | Day |
Date of closure to data entry
| 2015 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 11 | Month | 03 | Day |
Date analysis concluded
| 2015 | Year | 11 | Month | 30 | Day |
Other
Other related information
This is a retrospective study to determine the factors that are associated with the changes in serum FGF23 level in patients undergoing peritoneal dialysis. Among the patients who were registered to Fukuoka Peritoneal Dialysis Registry in December 2011, patients who received frozen serum collection at Kyushu University are recruited in the present study. We measures serum fibroblast growth factor 23 level using the frozen sera at baseline and at 18 month by commercially available ELISA kits. We also record clinical information related to peritoneal dialysis from the medical records. Clinical information includes age, sex, dialysis vintage, underlying kidney disease, serum biochemical parameters (calcium, phosphate, parathyroid hormone, albumin, urea nitrogen, creatinine), renal and peritoneal creatinine clearance, renal and peritoneal urea clearance, and use of medications (phosphate binder, vitamin D receptor activator, cinacalcet, and glucocorticoid).
The factors related to changes in serum fibroblast growth factor 23 level were determined by linear regression analyses.
Management information
Registered date
| 2015 | Year | 09 | Month | 23 | Day |
Last modified on
| 2016 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022066
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