UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001478 |
|---|---|
| Receipt number | 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 19:22:32 |
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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
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
Sponsor or person
Institute
Kitano Hospital
Division of Nephrology and Dialysis
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 | 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001793
