UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000250 |
|---|---|
| Receipt number | 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 10:28:40 |
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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
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
taka@medone.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Nephrology, Osaka University School of Medicine
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
Department of Internal Medicine and Therapeutics, Osaka University School of Medicine
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000315
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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