UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037181 |
|---|---|
| Receipt number | R000042376 |
| Scientific Title | Effect of low dose vitamin D on FGF23 levels in patients with non-dialysis-dependent chronic kidney disease |
| Date of disclosure of the study information | 2019/06/26 |
| Last modified on | 2024/01/02 14:44:45 |
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Basic information
Public title
Effect of low dose vitamin D on FGF23 levels in patients with non-dialysis-dependent chronic kidney disease
Acronym
Effect of low dose vitamin D on FGF23 levels in patients with non-dialysis-dependent chronic kidney disease
Scientific Title
Effect of low dose vitamin D on FGF23 levels in patients with non-dialysis-dependent chronic kidney disease
Scientific Title:Acronym
Effect of low dose vitamin D on FGF23 levels in patients with non-dialysis-dependent chronic kidney disease
Region
| Japan |
Condition
Condition
chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate the effect of low dose vitamin D on FGF23 levels in CKD patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
serum FGF23 levels in pre-vitamin D treatment and 6 months after
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
alfacalcidol 0.25ug 6 months
Interventions/Control_2
not treated with any vitamin D
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
15ml/min<eGFR<=60ml/min cCa<=10.0mg/dl
Key exclusion criteria
patients treated with vitamin D
not agreed
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Iguchi |
Organization
Nagaoka red cross hospital
Division name
Division of Clinical Nephrology
Zip code
940-2085
Address
2-297-1, Senshu, Nagaoka, Niigata
TEL
0258283600
igucci4444@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Iguchi |
Organization
Nagaoka red cross hospital
Division name
Division of Clinical Nephrology
Zip code
940-2085
Address
2-297-1 Senshu, Nagaoka, Niigata
TEL
0258283600
Homepage URL
igucci4444@yahoo.co.jp
Sponsor or person
Institute
Nagaoka red cross hospital
Institute
Department
Personal name
Funding Source
Organization
The Kidney Fundation Japan
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagaoka red cross hospital
Address
2-297-1 Senshu, Nagaoka, Niigata
Tel
0258283600
igucci4444@yahoo.co.jp
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
| 2019 | Year | 06 | Month | 26 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000042376
Publication of results
Published
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000042376
Number of participants that the trial has enrolled
107
Results
Serum 25(OH)D level in CKD patients may regulate the reaction of FGF23 for Vitamin D administration.
Results date posted
| 2024 | Year | 01 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
patients with CKD stage 3 and 4
Participant flow
We enrolled 80 participants in Nagaoka Red-Cross Hospital. The patients were aged 20 years or older and CKD stage G3 and 4 (15 ml/min/1.73m2 < eGFR < 60 ml/min/1.73m2).
Adverse events
nothing
Outcome measures
Ca iP PTH ALP FGF23 25OHD 1,25OHD FEiP FECa
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 06 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 06 | Month | 26 | Day |
Last modified on
| 2024 | Year | 01 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042376
| 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 |
