UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023536 |
|---|---|
| Receipt number | R000026953 |
| Scientific Title | Changes in FGF23 and soluble Klotho levels in incident hemodialysis patients |
| Date of disclosure of the study information | 2016/09/01 |
| Last modified on | 2017/08/09 19:16:56 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Changes in FGF23 and soluble Klotho levels in incident hemodialysis patients
Acronym
Changes in FGF23 and soluble Klotho levels in incident hemodialysis patients
Scientific Title
Changes in FGF23 and soluble Klotho levels in incident hemodialysis patients
Scientific Title:Acronym
Changes in FGF23 and soluble Klotho levels in incident hemodialysis patients
Region
| Japan |
Condition
Condition
End Stage Renal Disease
Classification by specialty
| Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine changes in FGF23 and soluble Klotho after initiation of hemodialysis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Decrease in FGF 23 in short-term after initiation of hemodialysis
Key secondary outcomes
Decrease in soluble Koltho and intact PTH in short-term after initiation of hemodialysis
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Incident dialysis patients with chronic renal failure
Key exclusion criteria
Switching from peritoneal dialysis and combination with peritoneal dialysis
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masafumi Fukagawa |
Organization
Tokai University School of Medicine
Division name
Division of Nephrology, Endocrinology and Metabolism
Zip code
Address
143 Shimo-Kasuya, Isehara, 259-1193, Japan
TEL
0463-93-1121
fukagawa@tokai-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chiaki Kawabata |
Organization
Tokai University School of Medicine
Division name
Division of Nephrology, Endocrinology and Metabolism
Zip code
Address
143 Shimo-Kasuya, Isehara, 259-1193, Japan
TEL
0463-93-1121
Homepage URL
superlatino818@gmail.com
Sponsor or person
Institute
Tokai University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Under application
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
| 2016 | Year | 09 | Month | 01 | 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
| 2016 | Year | 07 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
This prospective study examines changes in FGF23 and soluble Klotho in incident dialysis patients.
Management information
Registered date
| 2016 | Year | 08 | Month | 08 | Day |
Last modified on
| 2017 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026953
