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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000004633
Receipt No. 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

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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
Email

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
Email kyw620@hotmail.co.jp

Sponsor
Institute Nippon Kokan Fukuyama Hospital
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005357

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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