Unique ID issued by UMIN | UMIN000027408 |
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Receipt number | R000031402 |
Scientific Title | Clinical efficacy of intravenous calcium-sensing receptor agonist (etelcalcetide hydrochloride) for secondary hyperparathyroidism |
Date of disclosure of the study information | 2017/05/19 |
Last modified on | 2020/07/06 19:49:25 |
Clinical efficacy of intravenous calcium-sensing receptor agonist (etelcalcetide hydrochloride) for secondary hyperparathyroidism
Clinical efficacy of etelcalcetide hydrochloride for secondary hyperparathyroidism
Clinical efficacy of intravenous calcium-sensing receptor agonist (etelcalcetide hydrochloride) for secondary hyperparathyroidism
Clinical efficacy of etelcalcetide hydrochloride for secondary hyperparathyroidism
Japan |
End-stage renal disease
Nephrology |
Others
NO
To determine the effect of etelcalcetide hydrochloride on secondary hyperparathyroidism
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
Parathyroid hormone (PTH) value, corrected calcium value, and phosphorus value every 3 months after administration of ethelcarcitrate hydrochloride
Bone metabolism marker, bone density, and parathyroid volume every 6 months after the administration of ethelcarcitrate hydrochloride
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
5 micro gram of etelcalcetide hydrochloride is intravenously injected after each dialysis. The dose of etelcalcetide hydrochloride is appropriately increased or decreased depending on levels of intact PTH and corrected calcium measured each time.
20 | years-old | <= |
90 | years-old | >= |
Male and Female
Maintenance hemodialysis patients with Intact PTH> 240 pg / mL and corrected serum calcium 8.4 mg / dL or more
Hypocalcemic patients with corrected serum calcium level <8.4 mg / dL
50
1st name | Satoshi |
Middle name | |
Last name | Kurihara |
Saitama Tsukinomori Clinic
Department of Nephrology
339-0012
366-1 Mashinaga, Iwatsuki-ku, Saitama city, Saitama 339-0012, Japan
048-792-1811
kurihara@k-naika-cl.jp
1st name | Satoshi |
Middle name | |
Last name | Kurihara |
Saitama Tsukinomori Clinic
Department of Nephrology
339-0012
366-1 Mashinaga, Iwatsuki-ku, Saitama city, Saitama 339-0012, Japan
048-792-1811
kurihara@k-naika-cl.jp
Saitama Tsukinomori Clinic
Saitama Tsukinomori Clinic
Self funding
the ethics committee of Saitama Tsukinomori Clinic
366-1 Mashinaga, Iwatsuki-ku, Saitama city, Saitama 339-0012, Japan
0487921811
hayama@k-naika-cl.jp
NO
2017 | Year | 05 | Month | 19 | Day |
Unpublished
32
1.After changing/increasing cinacalcet from etelcalcetide, parathyroid hormone, bone-type alkaline phosphatase, osteocalcin, tartrate-resistant acid phosphatase, and fibroblast growth factor 23 decreased significantly within 12 months, and alkaline phosphatase also tended to decrease.
2.Hypocalcemia was seen in some cases after administration of etelcalcetide. Because hypocalcemia was treated with calcium correction, no obvious side effects due to hypocalcemia were observed.
2020 | Year | 07 | Month | 06 | Day |
Completed
2017 | Year | 05 | Month | 16 | Day |
2017 | Year | 05 | Month | 17 | Day |
2017 | Year | 05 | Month | 26 | Day |
2020 | Year | 03 | Month | 31 | Day |
The main results of this study are as follows.
1.After changing/increasing cinacalcet from etelcalcetide, parathyroid hormone, bone-type alkaline phosphatase, osteocalcin, tartrate-resistant acid phosphatase, and fibroblast growth factor 23 decreased significantly within 12 months, and alkaline phosphatase also tended to decrease.
2.Hypocalcemia was seen in some cases after administration of etelcalcetide. Because hypocalcemia was treated with calcium correction, no obvious side effects due to hypocalcemia were observed.
From these results, we conclude that etelcalcetide is an effective drug for secondary hyperparathyroidism and bone metabolism in hemodialysis patients.
The results of this study are presented below. Ono Yakuhin Web Seminar (Saitama, March 2018), Central district SHPT Seminar (Ageo, April 2018), CKD-MBD treatment seminar in Setagaya (Tokyo, May 2018), The 63rd Annual Meeting of the Japanese Society of Dialysis Therapy (Kobe, June 2018), The 48th Annual Meeting of the Japanese Society of Nephrology (Tokyo, October 2018), Ono Pharmaceutical Web Live Seminar (Saitama, December 2018), The 64th Annual Meeting of the Japanese Society of Dialysis Therapy (Yokohama, June 2019), Table Discussion Meeting in Saitama (Saitama, April 2019), SHPT Medical Seminar (Ageo, November 2019).
2017 | Year | 05 | Month | 19 | Day |
2020 | Year | 07 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031402
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