Unique ID issued by UMIN | UMIN000002784 |
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Receipt number | R000001919 |
Scientific Title | The effect of maxacalcitol on cardiovascular disesase in hemodialysis patients |
Date of disclosure of the study information | 2009/12/01 |
Last modified on | 2012/11/26 15:01:19 |
The effect of maxacalcitol on cardiovascular disesase in hemodialysis patients
MAX study
The effect of maxacalcitol on cardiovascular disesase in hemodialysis patients
MAX study
Japan |
Chronic kidney disease
Nephrology |
Others
NO
To investigate whether the maxacalcitol treatment prevent cardiovascular disease in hemodialysis patients, as compared with coventional therapy
Efficacy
Confirmatory
Pragmatic
Not applicable
Left ventricular mass index
Intimal plus medial complex thickness
Coronary artery calcification score
Pulse wave velocity
Dual energy X-ray absorptiometry
Bone metabolism marker
Inflamatory marker
Oxidative stress marker
Parathyroid gland volume
Correlation between bone and artery
Correlation between vitamin D level and vascular calcification
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
Maxacalcitol therapy
Conventional therpy (oral vitamin D treatment)
20 | years-old | <= |
80 | years-old | >= |
Male and Female
Hemodialysis patients
Within 2 years after the initiation of hemodialysis therapy
Serum intact PTH level more than 180pg/ml
Serum corrected calcium level less than 10.0mg/dl
Post history of intravenous vitamin D therapy
Post history of cicalcet HCl treatment
Post history of peritoneal dialysis or kidney transplantion
Pregnant woman
Post history of severe cardiovascular disease
52
1st name | |
Middle name | |
Last name | Kazuhiko Tsuruya |
Kyushu University, Graduate School of Medical Sciences
Department of Integrated Therapy for Chronic Kidney Disease
Maidashi 3-1-1, Higashi-ku, Fukuoka, Japan
092-642-5843
1st name | |
Middle name | |
Last name | Masatomo Taniguchi |
Kyushu University, Graduate School of Medical Sciences
Department of Medicine and Clinical Science
Maidashi 3-1-1, Higashi-ku, Fukuoka, Japan
092-642-5256
masatomo@kcu.med.kyushu-u.ac.jp
Department of Medicine and Clinical Science, Kyushu University
Chugai Pharmaceutical Co., Ltd.
Profit organization
NO
2009 | Year | 12 | Month | 01 | Day |
Unpublished
Enrolling by invitation
2009 | Year | 12 | Month | 01 | Day |
2009 | Year | 12 | Month | 01 | Day |
2014 | Year | 03 | Month | 01 | Day |
2009 | Year | 11 | Month | 19 | Day |
2012 | Year | 11 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001919
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