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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000250
Receipt No. R000000315
Scientific Title An Open-label controlled Trial to Assess the Efficacy of Bisphosphonate in the Treatment of Coronary Artery Calcification in Nondialyzed Patients with Diabetic Nephropathy.
Date of disclosure of the study information 2006/02/17
Last modified on 2007/09/28

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Basic information
Public title An Open-label controlled Trial to Assess the Efficacy of Bisphosphonate in the Treatment of Coronary Artery Calcification in Nondialyzed Patients with Diabetic Nephropathy.
Acronym Effect of Bisphosphonate on Coronary Artery Calcification in Diabetic Nephropathy
Scientific Title An Open-label controlled Trial to Assess the Efficacy of Bisphosphonate in the Treatment of Coronary Artery Calcification in Nondialyzed Patients with Diabetic Nephropathy.
Scientific Title:Acronym Effect of Bisphosphonate on Coronary Artery Calcification in Diabetic Nephropathy
Region
Japan

Condition
Condition Type 2 diabetic nephropathy
Classification by specialty
Cardiology Endocrinology and Metabolism Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This one year study will test the efficacy of etidronate in the treatment of coronary artery calcification by measuring CACS (coronary artery calcification score) of nondialyzed patients with diabetic nephropathy, who are randomly assigned to etidroante or to no-drug.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Changes in CACS after 1-year study period.
Key secondary outcomes Change in ultrasonographical intima media thickness (IMT) of the carotid artery, brachial ankle pulse wave velocity (baPWV), bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DXA), and serum concentration of bone turnover markers.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation
Institution consideration
Blocking
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Oral administration of etidronate
Interventions/Control_2 No drug that affects coronary artery calcification
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 Outpatients in Osaka University hospital with type 2 diabetic nephropathy whose Ccr is equal to or over 30 mL/min according to the estimation of Cockcroft-Gault's formula.
Either microalbuminuria (30 mg/dL/Cr or more) or proteinuria is required for the inclusion.
Key exclusion criteria Patients with atrial fibrillation, those who are contraindicated for beta-blockers, pregnant patients, or patients planning pregnancy are excluded.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahito Ito
Organization Osaka University School of Medicine
Division name Department of Nephrology
Zip code
Address 2-2 Yamadaoka, Suita, Osaka
TEL 06-6879-3632
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takahito Ito
Organization Osaka University School of Medicine
Division name Department of Nephrology
Zip code
Address 2-2 Yamadaoka, Suita, Osaka
TEL 06-6879-3632
Homepage URL
Email taka@medone.med.osaka-u.ac.jp

Sponsor
Institute Department of Nephrology, Osaka University School 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 Department of Internal Medicine and Therapeutics, Osaka University School of Medicine
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
2006 Year 02 Month 17 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 12 Month 28 Day
Date of IRB
Anticipated trial start date
2005 Year 09 Month 01 Day
Last follow-up date
2006 Year 12 Month 01 Day
Date of closure to data entry
2008 Year 03 Month 01 Day
Date trial data considered complete
2008 Year 03 Month 01 Day
Date analysis concluded
2008 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 09 Month 28 Day
Last modified on
2007 Year 09 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000315

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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