UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019385 |
|---|---|
| Receipt number | R000022419 |
| Scientific Title | Randomized trial for the chronic kidney disease patients by phosphate binder for prevention of vascular calcification in Juntendo University Hospital |
| Date of disclosure of the study information | 2015/10/16 |
| Last modified on | 2022/04/15 16:14:51 |
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Basic information
Public title
Randomized trial for the chronic kidney disease patients by phosphate binder for prevention of vascular calcification in Juntendo University Hospital
Acronym
CKDcalc-J
Scientific Title
Randomized trial for the chronic kidney disease patients by phosphate binder for prevention of vascular calcification in Juntendo University Hospital
Scientific Title:Acronym
CKDcalc-J
Region
| Japan |
Condition
Condition
chronic kidney disease patients
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the differnce of vascular calcification evaluated ultrasonography between lanthanum carbonate and ferric citrate hydrate administered group
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Vascular calcification and intima-media thickness evaluated carotid ultrasonography
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Lanthanum carbonate treatment (enrollment:until initiated dialysis or 2 years)
Interventions/Control_2
ferric citrate hydrate treatment (enrollment:until initiated dialysis or 2 years)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.chronic kidney disease patients
2.treatment for more than 6 months
3.serum phosphorus >4.5mg/dl
4.patientswith written informed consent
Key exclusion criteria
1.contraindication
2.Severe gastrointestinal tract disorders
3.already administred Lanthanum carbonate or ferric citrate hydrate
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Io |
Organization
Department of internal Medicine, Juntendo University Faculty of Medicine
Division name
Nephrology
Zip code
177-8521
Address
Takanodai 3-1-10, Nerima-ku,Tokyo
TEL
0359233111
hiroaki@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Io |
Organization
Department of internal Medicine, Juntendo University Faculty of Medicine
Division name
Nephrology
Zip code
177-8521
Address
3-1-10 Nerima-ku, Takanodai, Tokyo
TEL
0359233111
Homepage URL
hiroaki@juntendo.ac.jp
Sponsor or person
Institute
Department of internal Medicine, Juntendo University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
Juntendo University
Address
3-1-3 Bunkyou-ku, Hongo, Tokyo
Tel
03-3813-3111
hongo-rinri@juntendo.ac.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
| 2015 | Year | 10 | Month | 16 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 16 | Day |
Last modified on
| 2022 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022419
| 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 |
