UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002628
Receipt number R000003203
Scientific Title Prospective Study on the effects of cinacalcet HCL on vascular calcification and parathyroid glands size in patients on maintenance hemodialysis
Date of disclosure of the study information 2009/10/14
Last modified on 2009/10/14 17:07:25

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Basic information

Public title

Prospective Study on the effects of cinacalcet HCL on vascular calcification and parathyroid glands size in patients on maintenance hemodialysis

Acronym

Prospective Study on the effects of cinacalcet HCL on vascular calcification and parathyroid glands size in patients on maintenance hemodialysis

Scientific Title

Prospective Study on the effects of cinacalcet HCL on vascular calcification and parathyroid glands size in patients on maintenance hemodialysis

Scientific Title:Acronym

Prospective Study on the effects of cinacalcet HCL on vascular calcification and parathyroid glands size in patients on maintenance hemodialysis

Region

Japan


Condition

Condition

chronic kidney disease patients with hyperparathyroidism undergoing hemodialysis

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Cinacalcet HCL is given for secondary hyper parathyroid patients for one year.And multislice CT-determined coronary artery calcification score, parathyroid glands (PTG) size and blood parameters concentration are determined the effect of Cinacalcet HCL to inhibit the progression of coronary artery calcification and reduction of PTG.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Comparisons of the changes in PTGs` size , coronary artery calcification score and blood parameters concentration occurring during one year of test drug administration from enrollment

Key secondary outcomes



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

80 years-old >

Gender

Male and Female

Key inclusion criteria

1. Patients aged 20 years or older and younger than 80 years at the time of consent
2. Patients with chronic renal failure undergoing maintenance hemodialysis three times a week at dialysis facilities
3. Patients in need of phosphate binders with serum phosphorus <6.5 mg/dL, corrected serum calcium <10.2 mg/dL, and intact-PTH between 150 and 300 pg/mL immediately before enrollment

Key exclusion criteria

(Exclusion criteria that would otherwise affect outcomes)
1. Patients who have received the test drugs within 12 weeks of enrollment
2. Patients who have undergone parathyroidectomy within one year of enrollment
3. Patients who have undergone parathyroid-targeted interventions (intra-parathyroid injection of ethanol, acetic acid, or vitamin D and its derivatives) within 24 weeks of enrollment
4. Patients who have received bisphosphonate products within 12 weeks of enrollment
5. Patients on estrogen replacement therapy
6. Patients receiving elcitonin
7. Patients receiving nicotinamide
8. Patients receiving sodium ferrous citrate (Proprietary name: Ferromia and others)
9. Patients receiving ipriflavone (Proprietary name: Osten and others)
10. Patients receiving vitamin K2 (Proprietary name: Glakay and others)

(Exclusion criteria in consideration of safety)
1. Patients with severe gastrointestinal conditions
2. Patients infected with HIV
3. Patients with vasculitis or vascular disorders
4. Patients complicated with severe hepatic dysfunction or cirrhosis
5. Patients complicated with severe cardiac conditions (New York Heart Association Classification, Class III or higher)
6. Patients with uncontrollable diabetes
7. Patients with HbA1c 9% or higher
8. Patients with uncontrollable hypertension
9. Patients unfit for dialysis
10. Patients who are likely prone to severe drug allergy such as anaphylactic shock or who have past or current history of drug or alcohol intoxication
11. Women who are pregnant, lactating or suspected of pregnancy
12. Patients with serious complications such as malignancy and serious infections
13. Patients with any one of the contraindications indicated on the package insert of lanthanum carbonate
14. Patients who are judged unfit as subjects of the study by investigators, sub-investigators or collaborators

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takatoshi Kakuta

Organization

Tokai University School of Medicine

Division name

Division of Nephrology and Metabolism, Department of Internal Medicine

Zip code


Address

Shimokasuya 143, Isehara, Kanagawa 259-1193, Japan

TEL

0463-93-1121

Email



Public contact

Name of contact person

1st name
Middle name
Last name Takatoshi Kakuta

Organization

Tokai University School of Medicine

Division name

Division of Nephrology and Metabolism, Department of Internal Medicine

Zip code


Address

Shimokasuya 143, Isehara, Kanagawa 259-1193, Japan.

TEL

81-463-93-1121

Homepage URL


Email



Sponsor or person

Institute

Division of Nephrology and Metabolism, Department of Internal Medicine, Tokai University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

none

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


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



Other administrative information

Date of disclosure of the study information

2009 Year 10 Month 14 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


Results


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

No longer recruiting

Date of protocol fixation

2008 Year 01 Month 01 Day

Date of IRB


Anticipated trial start date

2008 Year 02 Month 01 Day

Last follow-up date

2009 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Prospective Study


Management information

Registered date

2009 Year 10 Month 14 Day

Last modified on

2009 Year 10 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003203


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name