UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027408
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

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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 or person

Institute

Saitama Tsukinomori Clinic

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031402


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name