臨床研究等提出・公開システム

Date of registration	May. 09, 2019
Last modified on	April. 27, 2024
Trial ID	jRCTs051190014

Scientific Title	On target management for secondary hyperparathyroidism by two calcimimetics (HP2C study)
Public Title	The comparison of calcimimetics (2C study)

Completion date	Dec. 31, 2019
Result actual enrolment	143
Baseline Characteristics	Patients with Secondary hyperparathyroidism undergoing maintenance hemodialysis. Male :82, female: 59, Mean age: 68.2 years old.
Participant flow	The change in patient number during study period: Patients number at the start of the study: Oral administration of Ca receptor agonist group:10. intravenous administration of Ca receptor agonist group: 24. Analysis: Although, the participant of this study reached target number, we performed an analysis in the participant.
Adverse events	There were no adverse events
Outcome measures	There was no significant difference in Ca and P levels between oral and intravenous administration of Ca receptor agonist. The decline of PTH level of intravenous administration of Ca receptor agonist was significantly higher than that of oral administration.
Brief summary	Both of oral and intravenous administration of Ca receptor agonist kept the target Ca, P, PTH levels. Patient treated with intravenous Ca receptor agonist of PTH rapidly decline and kept target PTH levels during study period.
Date of posting of results summaries	April. 27, 2024
Date of the first journal publication of results	May. 24, 2025

Plan to share IPD	No
Plan description	No plan
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCTs051190014

Contact for Scientific Queries	Name	Kuragano Takahiro
	Affiliation	The Hospital of Hyogo College of Medicine
	Address	1-1, Mukogawa-cho, Nishinomiya City, Hyogo Prefecture, Japan
	Telephone	+81-798-45-6521
	E-mail	jin@hyo-med.ac.jp
Contact for Public Queries	Name	Kuragano Takahiro
	Affiliation	The Hospital of Hyogo College of Medicine
	Address	1-1, Mukogawa-cho, Nishinomiya City, Hyogo Prefecture, Japan
	Telephone	+81-798-45-6521
	E-mail	jin@hyo-med.ac.jp

Recruitment status	Complete

Anticipated date of first enrollment		Nov. 04, 2017
Actual date of first enrollment		Dec. 04, 2017
Target sample size		300
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Maintenance hemodialysis patients with secondary hyperparathyroidism (int-PTH>240 pg/mL)
	Exclusion Criteria	Patients with sever heart failure (>NYHA III),liver dysfunction, respiratory failure, and malignant tumor.
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Chronic kidney disease
Intervention(s)		Arm A: 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. Arm B: 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.
Primary Outcome(s)		Achievement ratio for target levels of PTH, Ca, and P.
Secondary Outcome(s)		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.

Source of Monetary Support / Secondary Sponsor	ONO PHARMACEUTICAL CO., LTD
Secondary Sponsor	Not applicable

Source of Monetary Support	ONO PHARMACEUTICAL CO., LTD
Secondary Sponsor	Not applicable

Name of Certified Review Board	The Certified Review Board of Hyogo College of Medicine
Address	1-1, Mukogawa-cho, Nishinomiya City, Hyogo Prefecture, Japan, Hyogo
Telephone	+81-798-45-6066
E-Mail	rinken@hyo-med.ac.jp
Approval Status	Approval
Date of approval	Mar. 22, 2019

Secondary ID(s)	UMIN000029000
Issuing Authority	University Hospital Information Network (UMIN) Center

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	April. 27, 2024	(this page)	Changes
1	May. 09, 2019	Detail

List of change history