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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001478
Receipt No. R000001793
Scientific Title A combination of cinacalcet with maxacalcitol for regression of moderate to advanced secondary hyperparathyroidism in patients on chronic hemodialysis
Date of disclosure of the study information 2009/10/25
Last modified on 2010/12/18

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Basic information
Public title A combination of cinacalcet with maxacalcitol for regression of moderate to advanced secondary hyperparathyroidism in patients on chronic hemodialysis
Acronym Combined therapy of cinacalcet with maxacalcitol for regression of secondary hyperparathyroidism
Scientific Title A combination of cinacalcet with maxacalcitol for regression of moderate to advanced secondary hyperparathyroidism in patients on chronic hemodialysis
Scientific Title:Acronym Combined therapy of cinacalcet with maxacalcitol for regression of secondary hyperparathyroidism
Region
Japan

Condition
Condition secondary hyperparathyroidism
Classification by specialty
Endocrinology and Metabolism Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Inhibitory effect of a combination of cinacalcet with maxacalcitol on secondary hyperparathyroidism
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Indication of parathyroidectomy or other intervention therapy by sustained high intact PTH level (>1000 pg/ml)
Key secondary outcomes 1) Difficulty of management of calcium and phosphate by a combination of cinacalcet and maxacalcitol
2) Low iPTH (<30 pg/ml)
3) Adynamic bone
4) Cardiovascular events

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 High doses of cinacalcet and maxacalcitol
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 Chronic dialysis patients of intact PTH from 300 to 1000pg/ml under Ca 8.4-10.0mg/dl and P 3.0-6.0mg/dl
Key exclusion criteria 1) Uncontrolled ischemic heart disease, heart failure, and arrhythmia
2) Stroke within 6 months
3) Peripheral artery didease of Fontaine 3 and 4
4) Severe liver cirrhosis
5) Malignancy within 3 years
6) Uncontrolled phychosis
7) Attendant for other clinical studies within 3 months
8) Pregnant woman or man who wish for baby
9) Unsuitable patients
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsuo Tsukamoto
Organization Kitano Hospital, The Tazuke Kofukai Medical Institute
Division name Division of Nephrology and Dialysis
Zip code
Address 2-4-20 Ohgimachi, Kita-ku, Osaka
TEL 06-6312-8831
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuo Tsukamoto
Organization Kitano Hospital, The Tazuke Kofukai Medical Institute
Division name Division of Nephrology and Dialysis
Zip code
Address 2-4-20 Ohgimachi, Kita-ku, Osaka
TEL 06-6312-8831
Homepage URL
Email

Sponsor
Institute Kitano Hospital
Division of Nephrology and Dialysis
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 25 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2008 Year 04 Month 22 Day
Date of IRB
Anticipated trial start date
2008 Year 04 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
2008 Year 11 Month 03 Day
Last modified on
2010 Year 12 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001793

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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