UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of Etelcalcetide vs Cinacalcet in Hemodialyzed Patients with Secondary Hyperparathyroidism
Title of the study (Brief title)	Efficacy of Etelcalcetide vs Cinacalcet in Hemodialyzed Patients with Secondary Hyperparathyroidism
Region	Japan

Condition
Condition	Secondary Hyperparathyroidism
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the characteristics of etelcalcetide, etelcalcetide was administered to 50 hemodialysis outpatients at our hospital who were determined to require cinacalcet hydrochloride in accordance with The Clinical Practice Guideline for the Management of Chronic Kidney Disease-Mineral and Bone Disorder.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The endpoints were the levels of corrected serum calcium, serum phosphorus, intact PTH, tartrate-resistant acid phosphatase (TRACP)-5b, and bone-type alkaline phosphatase (BAP). The mean corrected serum calcium, serum phosphorus, and intact PTH levels for 24 weeks before the start of treatment with etelcalcetide (pre-treatment values) were compared with those for 24 weeks after the start of treatment (post-treatment values). The mean TRACP-5b and BAP levels at the start of treatment (pre-treatment values) with etelcalcetide were also compared with those for 24 weeks after the start of treatment (post-treatment values). In addition, the endpoints were compared among treatment groups: cinacalcet hydrochloride-free group (n=8), low-dose cinacalcet hydrochloride/etelcalcetide group (switched from cinacalcet hydrochloride <26 mg/day to etelcalcetide; n=29), and high-dose cinacalcet hydrochloride/etelcalcetide group (switched from cinacalcet hydrochloride > 26 mg/day to etelcalcetide; n=13).
Key secondary outcomes	Whether or not the mean corrected serum calcium level significantly differed between the 19 subjects who underwent a washout period and the 23 subjects who did not, after the start of treatment with etelcalcetide.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Gender	Male and Female
Key inclusion criteria	The subjects were hemodialysis outpatients at our hospital with high PTH levels and high or normal serum phosphorus or calcium levels. Therefore, according to the 9-section chart for maintaining optimal levels of serum phosphorus and calcium of the Clinical Practice Guideline for the Management of Chronic Kidney Disease-Mineral and Bone Disorder.
Key exclusion criteria	Ineligible for the study as judged by the investigator
Target sample size	50

Research contact person
Name of lead principal investigator	Naofumi Ikeda
Organization	Saitama Sekishinkai Hospital
Division name	Department of Nephrology
Address	2-37-20 Irumagawa, Sayama, Saitama, 350-1305,Japan
TEL	04-2953-6611
Email	naofumi-ikeda@saitama-sekishinkai.org

Public contact
Name of contact person	Naofumi Ikeda
Organization	Saitama Sekishinkai Hospital
Division name	Department of Nephrology
Address	2-37-20 Irumagawa, Sayama, Saitama, 350-1305,Japan
TEL	04-2953-6611
Homepage URL
Email	naofumi-ikeda@saitama-sekishinkai.org

Sponsor
Institute	Saitama Sekishinkai Hospital
Institute
Department

Funding Source
Organization	Saitama Sekishinkai Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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	2018 Year 09 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 12 Month 01 Day
Anticipated trial start date	2017 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	observation study

Management information
Registered date	2018 Year 09 Month 15 Day
Last modified on	2018 Year 09 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038830