UMIN-CTR Clinical Trial

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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