UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000027408
Receipt No. 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 (Ver. 17)

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Basic information
Public title Clinical efficacy of intravenous calcium-sensing receptor agonist (etelcalcetide hydrochloride) for secondary hyperparathyroidism
Acronym Clinical efficacy of etelcalcetide hydrochloride for secondary hyperparathyroidism
Scientific Title Clinical efficacy of intravenous calcium-sensing receptor agonist (etelcalcetide hydrochloride) for secondary hyperparathyroidism
Scientific Title:Acronym Clinical efficacy of etelcalcetide hydrochloride for secondary hyperparathyroidism
Region
Japan

Condition
Condition End-stage renal disease
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the effect of etelcalcetide hydrochloride on secondary hyperparathyroidism
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Parathyroid hormone (PTH) value, corrected calcium value, and phosphorus value every 3 months after administration of ethelcarcitrate hydrochloride
Key secondary outcomes Bone metabolism marker, bone density, and parathyroid volume every 6 months after the administration of ethelcarcitrate hydrochloride

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 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.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria Maintenance hemodialysis patients with Intact PTH> 240 pg / mL and corrected serum calcium 8.4 mg / dL or more
Key exclusion criteria Hypocalcemic patients with corrected serum calcium level <8.4 mg / dL
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Satoshi
Middle name
Last name Kurihara
Organization Saitama Tsukinomori Clinic
Division name Department of Nephrology
Zip code 339-0012
Address 366-1 Mashinaga, Iwatsuki-ku, Saitama city, Saitama 339-0012, Japan
TEL 048-792-1811
Email kurihara@k-naika-cl.jp

Public contact
Name of contact person
1st name Satoshi
Middle name
Last name Kurihara
Organization Saitama Tsukinomori Clinic
Division name Department of Nephrology
Zip code 339-0012
Address 366-1 Mashinaga, Iwatsuki-ku, Saitama city, Saitama 339-0012, Japan
TEL 048-792-1811
Homepage URL
Email kurihara@k-naika-cl.jp

Sponsor
Institute Saitama Tsukinomori Clinic
Institute
Department

Funding Source
Organization Saitama Tsukinomori Clinic
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization the ethics committee of Saitama Tsukinomori Clinic
Address 366-1 Mashinaga, Iwatsuki-ku, Saitama city, Saitama 339-0012, Japan
Tel 0487921811
Email hayama@k-naika-cl.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 05 Month 19 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 32
Results 
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.
Results date posted
2020 Year 07 Month 06 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 05 Month 16 Day
Date of IRB
2017 Year 05 Month 17 Day
Anticipated trial start date
2017 Year 05 Month 26 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 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).

Management information
Registered date
2017 Year 05 Month 19 Day
Last modified on
2020 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031402