UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004212
Receipt number R000005061
Scientific Title The effects of cinacalcet hydrochloride on the regression of the parathryoid gland hyperplasia
Date of disclosure of the study information 2010/10/01
Last modified on 2015/01/05 15:41:50

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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