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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002628
Receipt No. 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

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

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
URL(English) https://upload.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


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