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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002150
Receipt No. R000002611
Scientific Title Open-label multicenter randomized trial on the effects of sevelamer hydrochloride and calcium carbonate on vascular calcification in patients on maintenance hemodialysis
Date of disclosure of the study information 2009/07/01
Last modified on 2009/07/01

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Basic information
Public title Open-label multicenter randomized trial on the effects of sevelamer hydrochloride and calcium carbonate on vascular calcification in patients on maintenance hemodialysis
Acronym Randomized trial on the effect of sevelamer hydrochloride on vascular calcification in hemodialysis patients
Scientific Title Open-label multicenter randomized trial on the effects of sevelamer hydrochloride and calcium carbonate on vascular calcification in patients on maintenance hemodialysis
Scientific Title:Acronym Randomized trial on the effect of sevelamer hydrochloride on vascular calcification in hemodialysis patients
Region
Japan

Condition
Condition Coronary artery calcification in chronic renal failure patients undergoing hemodialysis
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Either sevelamer hydrochloride or calcium carbonate is given for hyperphosphatemia to hemodialysis patients for one year, and multislice CT-determined coronary artery calcification score and blood parameters including pentosidine concentration are compared to determine the effect of sevelamer hydrochloride to inhibit the progression of coronary artery calcification.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Group-to-group comparisons of the changes in coronary artery calcification score and blood parameters including plasma pentosidine concentration occurring during one year of test drug administration from enrollment
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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 One-year treatment with sevelamer hydrochloride alone or combined use of sevelamer hydrochloride and calcium-based products
Interventions/Control_2 One-year treatment with calcium carbonate alone
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1. Patients aged 20 years or older and younger than 80 years at the time of consent
2. Patients with chronic renal failure undergoing maintenance hemodialysis three times a week at dialysis facilities
3. Patients in need of phosphate binders with serum phosphorus <6.5 mg/dL, corrected serum calcium <10.2 mg/dL, and intact-PTH between 150 and 300 pg/mL immediately before enrollment
Key exclusion criteria 1. Patients who have received the test drugs within 12 weeks of enrollment
2. Patients who have undergone parathyroidectomy within one year of enrollment
3. Patients who have undergone parathyroid-targeted interventions (intra-parathyroid injection of ethanol, acetic acid, or vitamin D and its derivatives) within 24 weeks of enrollment
4. Patients who have received bisphosphonate products within 12 weeks of enrollment
5. Patients on estrogen replacement therapy
6. Patients receiving elcitonin
7. Patients receiving nicotinamide
8. Patients receiving sodium ferrous citrate (Proprietary name: Ferromia and others)
9. Patients receiving ipriflavone (Proprietary name: Osten and others)
10. Patients receiving vitamin K2
Target sample size 260

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takatoshi Kakuta
Organization Tokai University School of Medicine
Division name Division of Nephrology and Metabolism, Department of Internal Medicine
Zip code
Address Shimokasuya 143, Isehara, Kanagawa 259-1193, Japan.
TEL 0463-93-1121
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Tokai University School of Medicine
Division name Division of Nephrology and Metabolism, Department of Internal Medicine
Zip code
Address Shimokasuya 143, Isehara, Kanagawa, Japan
TEL
Homepage URL
Email

Sponsor
Institute Division of Nephrology and Metabolism, Department of Internal Medicine,Tokai University School of Medicine
Institute
Department

Funding Source
Organization The Japan Dialysis Outcomes Research Group
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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
2009 Year 07 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
2004 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2004 Year 04 Month 01 Day
Last follow-up date
2006 Year 12 Month 01 Day
Date of closure to data entry
2009 Year 06 Month 01 Day
Date trial data considered complete
2009 Year 06 Month 01 Day
Date analysis concluded
2009 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 07 Month 01 Day
Last modified on
2009 Year 07 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002611

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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