Unique ID issued by UMIN | UMIN000029000 |
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Receipt number | R000033167 |
Scientific Title | On target management for secondary hyperparathyroidism by two calcimimetics (HP2C study) |
Date of disclosure of the study information | 2017/10/01 |
Last modified on | 2017/09/05 10:34:13 |
On target management for secondary hyperparathyroidism by two calcimimetics (HP2C study)
HP2C study
On target management for secondary hyperparathyroidism by two calcimimetics (HP2C study)
HP2C study
Japan |
Chronic kidney disease
Nephrology |
Others
NO
The purpose of this study is the comparison of the effectiveness on the managements of PTH, Ca,and P between etelcalcetide and cinacalcet, and the impact of these drugs on other clinical parameters.
Safety,Efficacy
Achievement ratio for target levels of PTH, Ca, and P.
1) Bone metabolism marker. 2) Bone density. 3) Intestinal bacteria. 4) Arteriosclerosis index. 5) Drugs. 6) Anemia and iron-related factor. 7) The taking medicine situation. 8) Symptom. 9) Medical economic effect.
Interventional
Parallel
Randomized
Cluster
Open -no one is blinded
Active
2
Treatment
Medicine |
According to the clinical practice guideline for the management of chronic kidney disease-meneral and bone disease (JSDT 2012), treated with intravenous calcimimetics (etelcalcetide) for 1 year.
According to the clinical practice guideline for the management of chronic kidney disease-meneral and bone disease (JSDT 2012), treated oral calcimimetics (cinacalcet) for 1 year.
20 | years-old | <= |
Not applicable |
Male and Female
Maintenance hemodialysis patients with secondary hyperparathyroidism (int-PTH>240 pg/mL)
Patients with sever heart failure (>NYHA III),liver dysfunction, respiratory failure, and malignant tumor.
300
1st name | |
Middle name | |
Last name | Takeshi Nakanishi |
Hyogo College of Medicine
Department of Internal Medicine, Division of Kidney and dialysis
1-1, Mukogawa cho, Nishinomiyaya, Hyogo
0798-45-6521
jin@hyo-med.ac.jp
1st name | |
Middle name | |
Last name | Takahiro Kuragano |
Hyogo College of Medicine
Department of Internal Medicine, Division of Kidney and dialysis
1-1, Mukogawa cho, Nishinomiyaya, Hyogo
0798-45-6521
kuragano@hyo-med.ac.jp
Hyogo College of Medicine
ONO PHARMACEUTICAL CO., LTD.
Profit organization
NO
2017 | Year | 10 | Month | 01 | Day |
Unpublished
Preinitiation
2017 | Year | 09 | Month | 05 | Day |
2017 | Year | 10 | Month | 01 | Day |
2017 | Year | 09 | Month | 05 | Day |
2017 | Year | 09 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033167
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