UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000019385
Receipt No. 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 2015/10/16

* 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 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
Middle name
Last name Satoshi Horikoshi
Organization Department of internal Medicine, Juntendo University Faculty of Medicine
Division name Nephrology
Zip code
Address 3-1-3 Bunkyou-ku, Hongo, Tokyo
TEL 03-3813-3111
Email satoshi@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroaki Io
Organization Department of internal Medicine, Juntendo University Faculty of Medicine
Division name Nephrology
Zip code
Address 3-1-3 Bunkyou-ku, Hongo, Tokyo
TEL 03-3813-3111
Homepage URL
Email chiken@juntendo.ac.jp

Sponsor
Institute Department of internal Medicine, Juntendo University Faculty of Medicine
Institute
Department

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
Address
Tel
Email

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
2015 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022419

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.