UMIN-CTR Clinical Trial

Basic information
Public title	The effects of cinacalcet hydrochloride on the regression of the parathryoid gland hyperplasia
Acronym	REG study
Scientific Title	The effects of cinacalcet hydrochloride on the regression of the parathryoid gland hyperplasia
Scientific Title:Acronym	REG study
Region	Japan

Condition
Condition	Secondary hyperparathyroidism under hemodialysis therapy
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the clinical effects of cinacalcet on the parathyroid gland volume in patients with moderate to advanced secondary hyperparathyroidism
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	The changes in parathyroid gland volume after cinacalcet hydrochloride treatment
Key secondary outcomes	Serial changes in the serum levels of intact PTH, corrected calcium, phosphorus and alkaline phosphatase, and in the doses of drugs used for secondary hyperparathyroidism

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Administration of cinacalcet hydrochloride to hemodialysis patients with moderate to advanced secondary hyperparathyroidism
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1)Patients with a history of more than 6 months of hemodialysis therapy, 2) patients with secondary hyperparathyroidism refractory to conventional medical treatment, 3) patients with serum intact PTH of more than 180 pg/ml and serum corrected calcium of more than 9mg/dl, 4) patiens who newly start to recieve cinacalcet treatment
Key exclusion criteria	Patients who have a past history of surgical parathyroidectomy and percutaneous ethanol injection therapy are excluded. In addition, patients who have been suffered from lifethreatening medical conditios such as malignancy or severe infection.
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazuhiko Tsuruya
Organization	Kyushu University
Division name	Department of Chronic Kidney Disease, Graduate School of Medical Science
Zip code
Address	3-1-1Maidashi, Higashi-ku, Fukuoka, Japan
TEL	092-642-5843
Email

Public contact
Name of contact person	1st name Middle name Last name Masatomo Taniguchi
Organization	Kyusuhu University
Division name	Department of Medicien and Clinical Science
Zip code
Address	3-1-1Maidashi, Higashi-ku, Fukuoka, Japan
TEL	092-642-5843
Homepage URL
Email	masatomo@kcu.med.kyushu-u.ac.jp

Sponsor
Institute	Department of Chronic Kidney Disease, Graduate School of Medical Science, Kyushu University
Institute
Department

Funding Source
Organization	Department of Medicine and Clinical Sicence, Graduate School of Medical Sciences, Kyushu University
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	九州大学病院(福岡県)

Other administrative information
Date of disclosure of the study information	2010 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results	Two years of treatment with cinacalcet hydrochloride significantly decreased parathryoid gland volumes, independent of the baseline PTH values and parathyroid gland volumes in 60 hemodialysis patients with secondary hyperparathyroidism. During the treatment period, serum PTH valuse increased in some patients, indicating that some patients showed resistance to cinacalcet treatment.
Results date posted
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	2008 Year 01 Month 13 Day
Date of IRB
Anticipated trial start date	2008 Year 02 Month 01 Day
Last follow-up date	2010 Year 12 Month 01 Day
Date of closure to data entry	2011 Year 01 Month 01 Day
Date trial data considered complete	2011 Year 01 Month 01 Day
Date analysis concluded	2011 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date	2010 Year 09 Month 15 Day
Last modified on	2015 Year 01 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005061

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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