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UMIN-CTR Clinical Trial |
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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 |
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 | |
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Condition | ||||
Condition | Type 2 diabetic nephropathy | |||
Classification by specialty |
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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 |
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Interventions/Control_1 | Oral administration of etidronate | |
Interventions/Control_2 | No drug that affects coronary artery calcification | |
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Eligibility | ||||
Age-lower limit |
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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. |
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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 |
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Name of lead principal investigator |
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Organization | Osaka University School of Medicine | ||||||
Division name | Department of Nephrology | ||||||
Zip code | |||||||
Address | 2-2 Yamadaoka, Suita, Osaka | ||||||
TEL | 06-6879-3632 | ||||||
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Name of contact person |
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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 | |
Institute | Department of Nephrology, Osaka University School of Medicine |
Institute | |
Department |
Funding Source | |
Organization | none |
Organization | |
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Category of Funding Organization | Self funding |
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Other related organizations | |
Co-sponsor | Department of Internal Medicine and Therapeutics, Osaka University School of Medicine |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
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Study ID_2 | |
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IND to MHLW |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
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Recruitment status | Completed | ||||||
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Last modified on |
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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 | |
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Research case data | |
Registered date | File name |