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
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
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
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
