UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004633 |
|---|---|
| Receipt number | R000005357 |
| Scientific Title | Evaluation of the treatment of hyperphosphatemia in hemodialysis patients with diabetes mellitus |
| Date of disclosure of the study information | 2010/12/01 |
| Last modified on | 2010/11/30 13:26:00 |
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Basic information
Public title
Evaluation of the treatment of hyperphosphatemia in hemodialysis patients with diabetes mellitus
Acronym
Evaluation of the treatment of hyperphosphatemia in hemodialysis patients with diabetes mellitus
Scientific Title
Evaluation of the treatment of hyperphosphatemia in hemodialysis patients with diabetes mellitus
Scientific Title:Acronym
Evaluation of the treatment of hyperphosphatemia in hemodialysis patients with diabetes mellitus
Region
| Japan |
Condition
Condition
To compare the difference of vascular calcification between lanthanum carbonate and calcium carbonate administered group in hemodialysis patients with diabetes mellitus
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the difference of vascular calcification between lanthanum carbonate and calcium carbonate administered group in hemodialysis patients with diabetes mellitus
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Abdominal aortic calcification
Key secondary outcomes
-Serum phosphate,calcium and intact-PTH
-Bone metabolism markers (osteocalcin and bone alkaline phosphatase)
-Bone density
-Calcification evaluated by PWV,IMT and parathyroid ultrasonography
-Nutritional assessment
-Dose of vitamin D
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Lanthanum carbonate treatment for 1 year
Interventions/Control_2
Calcium carbonate treatment for 1 year
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
-Hemodialysis patients with diabetes mellitus (good glycemic controlled patients)
-Patients under good control on maintenance hemodialysis (dialysis period: less than 5 years)
-Patients treated with phosphate binder for problems related to hyperphosphatemia
-Patients signed informed consent document
Key exclusion criteria
-Patients with poor glycemic control
-Patients with severe vascular complication
-Patients who meet the contraindication criteria in package insert of lanthanum carbonate or calcium carbonate
-Pregnant or possibly pregnant patients, patients on lactation
-Inappropriate patients for this study according to the investigator's judgement
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kentaro Wada |
Organization
Nippon Kokan Fukuyama Hospital
Division name
Division of Nephrology and Dialysis, Department of Internal Medicine
Zip code
Address
1844 Tsunoshita, Daimon-cho, Fukuyama, Hiroshima, Japan
TEL
+81-84-945-3106
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kentaro Wada |
Organization
Nippon Kokan Fukuyama Hospital
Division name
Division of Nephrology and Dialysis, Department of Internal Medicine
Zip code
Address
1844 Tsunoshita, Daimon-cho, Fukuyama, Hiroshima, Japan
TEL
+81-84-945-3106
Homepage URL
kyw620@hotmail.co.jp
Sponsor or person
Institute
Nippon Kokan Fukuyama Hospital
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
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
日本鋼管福山病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | 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
No longer recruiting
Date of protocol fixation
| 2010 | Year | 08 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 11 | Month | 30 | Day |
Last modified on
| 2010 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005357
| 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 |
