Unique ID issued by UMIN | UMIN000002769 |
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Receipt number | R000003359 |
Scientific Title | Evaluation of cinacalcet on clinical outcome depending on serum PTH level in Japanese patients with SHPT:ECO study |
Date of disclosure of the study information | 2009/11/18 |
Last modified on | 2011/11/16 14:10:56 |
Evaluation of cinacalcet on clinical outcome depending on serum PTH level in Japanese patients with SHPT:ECO study
Evaluation of cinacalcet on clinical outcome for in Japanese patients with SHPT:ECO study
Evaluation of cinacalcet on clinical outcome depending on serum PTH level in Japanese patients with SHPT:ECO study
Evaluation of cinacalcet on clinical outcome for in Japanese patients with SHPT:ECO study
Japan |
Secondary hyperparathyroidism
Nephrology |
Others
NO
estimate the impact of clinical outcome depending on serum PTH level in Japanese patients with SHPT
Safety,Efficacy
the proportion of patients who achieve JSDT guideline targets
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
administration of Cinacalcet HCl
Not applicable |
Not applicable |
Male and Female
Subjects were eligible for the study if they met the following criteria:
1. intact PTH over 180 pg/ml and Ca over 9.0mg/dl and P over 3.5mg/dl
2. intact PTH from 60 to 180pg/ml over Ca 10.0mg/dl and P 3.5mg/dl
or intact PTH from 60 to 180pg/ml over Ca 9.0mg/dl and P 6.0mg/dl
1. pregnant woman
2.received therapy with bisphosphonate within 24 weeks before IC
3.received therapy with estrogen hormone when signed IC
4.severe hepatic dysfunction or cirrhosis
5. drug allergies
6. malignancy
7. unsuitable patients
120
1st name | |
Middle name | |
Last name | Tatsuo Hosoya |
The Jikei University School of Medicine
Division of Kidney and Hypertension, Department of Internal Medicine
3-19-18, Nishi-Shimbashi, Minato-ku,Tokyo
1st name | |
Middle name | |
Last name | Keitaro Yokoyama |
The Jikei University School of Medicine
Division of Kidney and Hypertension, Department of Internal Medicine
3-19-18, Nishi-Shimbashi, Minato-ku,Tokyo
Division of Kidney and Hypertension, Department of Internal Medicine,The Jikei University School of Medicine
none
Self funding
NO
2009 | Year | 11 | Month | 18 | Day |
Unpublished
Completed
2008 | Year | 02 | Month | 05 | Day |
2008 | Year | 03 | Month | 01 | Day |
2010 | Year | 03 | Month | 01 | Day |
2009 | Year | 11 | Month | 16 | Day |
2011 | Year | 11 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003359
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