UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002150 |
|---|---|
| Receipt number | 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 14:12:26 |
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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
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
Sponsor or person
Institute
Division of Nephrology and Metabolism, Department of Internal Medicine,Tokai University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002611
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| Registered date | File name |
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