Unique ID issued by UMIN | UMIN000030354 |
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Receipt number | R000034658 |
Scientific Title | Evaluation of calcimimetic therapy in hemodialysis patients with secondary hyperparathyroidism: a real-world observational study |
Date of disclosure of the study information | 2017/12/11 |
Last modified on | 2022/11/22 17:49:30 |
Evaluation of calcimimetic therapy in hemodialysis patients with secondary hyperparathyroidism: a real-world observational study
ETERNAL Study
Evaluation of calcimimetic therapy in hemodialysis patients with secondary hyperparathyroidism: a real-world observational study
ETERNAL Study
Japan |
Hemodialysis patients with secondary hyperparathyroidism
Cardiology | Endocrinology and Metabolism | Nephrology |
Urology |
Others
NO
The objective of this study evaluate all deaths and hospitalization due to cardiovascular events in hemodialysis patients with secondary hyperparathyroidism .
Safety,Efficacy
Combined end-point of all deaths and hospitalization due to cardiovascular events
Observational
20 | years-old | <= |
Not applicable |
Male and Female
1) Patients 20 years of age or older at the time of consent
2) Patients able to provide written consent themselves
3) Hemodialysis patients with secondary hyperparathyroidism who satisfy the following 3 conditions:
(1) Patients with an iPTH value of 300 pg/mL or above (wPTH of 177 pg/mL or above)
(2) Patients with a corrected calcium concentration of 9.0 mg/dL or above (ionized calcium of 2.25 mEq/L or above)
(3) Patients being treated with an active vitamin D preparation alone, cinacalcet alone, or a combination of both
1) Patients with history of hemodialysis for less than 3 months at the time of eligibility confirmation
2) Patients who are inpatients at the time of eligibility confirmation
3) Patients who are planned to undergo surgery or be admitted to hospital at the time of eligibility confirmation where this will affect evaluation
4) Patients determined to be unsuitable for registration by the lead principal investigator or subinvestigator
3000
1st name | Masaru |
Middle name | |
Last name | Kawashima |
Ono Pharmaceutical Co.,ltd.
Department of Medical Affairs, Primary Medical Affairs Division
541-8564
8-2, Kyutaromachi 1-Chome, Chuo-ku, Osaka, 541-8564, JAPAN
06-6263-2992
eternal@ono.co.jp
1st name | Ami |
Middle name | |
Last name | Kitada |
Mebix Inc.
Clinical Research Division
107-0052
Akasaka Intercity, 1-11-44 Akasaka, Minato-ku, Tokyo, Japan 107-0052
0120-956-411
eternal-study@mebix.co.jp
Ono Pharmaceutical Co.,ltd.
Ono Pharmaceutical Co.,ltd.
Profit organization
Adachi Kyosai Hospital, ethics committee
1-36-8, Yanagihara, Adachi-ku, Tokyo
03-3881-6116
yama.chike2@gmail.com
NO
2017 | Year | 12 | Month | 11 | Day |
Unpublished
No longer recruiting
2017 | Year | 11 | Month | 01 | Day |
2017 | Year | 11 | Month | 30 | Day |
2017 | Year | 12 | Month | 11 | Day |
2022 | Year | 11 | Month | 30 | Day |
At present, etelcalcetide can be used as a new calcimimetic and the range of treatments has expanded, however the preventative effect of this drug on cardiovascular disease has not been sufficiently studied. Therefore, we decided to evaluate the long-term prognostic effect of etelcalcetide in an observational study on hemodialysis patients with secondary hyperparathyroidism and high PTH on existing treatment.
2017 | Year | 12 | Month | 11 | Day |
2022 | Year | 11 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034658
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