Unique ID issued by UMIN | UMIN000024439 |
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Receipt number | R000028128 |
Scientific Title | evaluation of Alendronate pharmacokinetics parameters in hemodialysis patients |
Date of disclosure of the study information | 2016/10/24 |
Last modified on | 2017/04/28 12:15:25 |
evaluation of Alendronate pharmacokinetics parameters in hemodialysis patients
Alpha-HD
evaluation of Alendronate pharmacokinetics parameters in hemodialysis patients
Alpha-HD
Japan |
osteoporosis
Medicine in general | Nephrology |
Others
NO
To evaluate the plasma concentration after intravenous administration of 900 ug alendronate.
PK,PD
the plasm concentration of alendronate
Observational
20 | years-old | <= |
Not applicable |
Male and Female
Hemodialysis
1) patients whose age is not less than 20 years old
2) general condition is good
3) Patients who have maintained dialysis therapy for over 6 months
4) Patients who have already diagnosed osteoporosis and treated with alendronate
5) the investigator judge the patients to be appropriate to participate in the study
non-hemodialysis
1) patients whose age is not less than 20 years old
2) Patients who have already diagnosed osteoporosis and treated with alendronate
3) Creatinine clearance: more than 45 ml/min.
4) the investigator judge the patients to be appropriate to participate in the study
1) Patients with severe liver disease
2) Patients with severe heart disease
3) Patients may be pregnant
4) Patients who have bad oral consitions
5) Patients who are thought to be inappropriate for this study by physician.
4
1st name | |
Middle name | |
Last name | Makoto Watanabe |
Makita general hospital
Internal medicine
1-34-6 Omorikita, Ohta-ku, Tokyo
03-3762-4671
makotonb@med.showa-u.ac.jp
1st name | |
Middle name | |
Last name | Ken Iseri |
Makita general hospital
Internal medicine
1-34-6 Omorikita, Ohta-ku, Tokyo
03-3762-4671
iseriken@med.showa-u.ac.jp
Makita general hospital
self funding
Self funding
NO
2016 | Year | 10 | Month | 24 | Day |
Unpublished
Completed
2016 | Year | 10 | Month | 17 | Day |
2016 | Year | 10 | Month | 24 | Day |
observation study
2016 | Year | 10 | Month | 17 | Day |
2017 | Year | 04 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028128
Research Plan | |
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Registered date | File name |
2017/04/28 | Alpha-HD study_pre実施計画書修正 1016.docx |
Research case data specifications | |
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Registered date | File name |
Research case data | |
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Registered date | File name |