UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014819 |
|---|---|
| Receipt number | R000017152 |
| Scientific Title | Cholecalciferol Supplementation for Anemia and Mineral and Bone Disorder in Hemodialysis Patients (CHAMBER): A Multicenter, Double-blind, Randomized, Placebo-controlled Trial |
| Date of disclosure of the study information | 2014/08/15 |
| Last modified on | 2016/08/12 12:01:24 |
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Basic information
Public title
Cholecalciferol Supplementation for Anemia and Mineral and Bone Disorder in Hemodialysis Patients (CHAMBER): A Multicenter, Double-blind, Randomized, Placebo-controlled Trial
Acronym
Cholecalciferol Supplementation for Anemia and Mineral and Bone Disorder in Hemodialysis Patients (CHAMBER)
Scientific Title
Cholecalciferol Supplementation for Anemia and Mineral and Bone Disorder in Hemodialysis Patients (CHAMBER): A Multicenter, Double-blind, Randomized, Placebo-controlled Trial
Scientific Title:Acronym
Cholecalciferol Supplementation for Anemia and Mineral and Bone Disorder in Hemodialysis Patients (CHAMBER)
Region
| Japan |
Condition
Condition
End-stage renal disease requiring hemodialysis
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1) To evaluate the effect of cholecalciferol supplementation on anemia and bone and mineral disorder in hemodialysis patients.
2) To compare the effect of 2 different administration schedule (thrice-weekly and once-monthly) of cholecalciferol.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Serum hepcidin-25 concentrations at day 3 and the 3rd month
Key secondary outcomes
1) Serum hepcidin-25 concentrations at the 6th month
2) Percent change of ERI (erythropoietin resistance index) overtime (up to the 6th month)
* ERI = Average weekly dose of ESA over prior 4 weeks / post-dialysis body weight (kg) / Hb (g/dL)
3) Blood concentrations of calcium, phosphate, and intact parathyroid hormone overtime (up to the 6th month)
4) Blood concentrations of high-sensitive CRP, IL-6, and TNF-alpha at day 3, the 3rd month, and the 6th month
5) Blood concentrations of 1,25-dihydroxyvitamin D, bone specific alkaline phosphatase, and tartrate-resistant acid phosphatase (TRAcP) 5b at the 3rd months and the 6th month
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine | Food |
Interventions/Control_1
Thrice-weekly cholecalciferol (3,000 IU) supplementation
Interventions/Control_2
Thrice-weekly placebo
Interventions/Control_3
Monthly cholecalciferol supplementation equivalent to 9,000 IU/week
Interventions/Control_4
Monthly placebo
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with end-stage renal disease receiving thrice-weekly maintenance hemodialysis
2) On treatment with erythropoietin stimulating agent
3) With written informed concent
Key exclusion criteria
1) On treatment with epoetin beta pegol as ESA
2) On supplementation with native vitamin D
3) Hypercalcemia (>=10.5 mg/dL ofcorrected serum calcium)
4) On treatment with intravenous iron agents
5) Judged as ineligible to the randomized study by the investigators
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takayuki Hamano |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Comprehensive Kidney Disease Research
Zip code
Address
2-2, Yamada-oka, Suita, Osaka, Japan
TEL
06-6879-3857
tsubakihara@kid.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayuki Hamano |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Comprehensive Kidney Disease Research
Zip code
Address
2-2, Yamada-oka, Suita, Osaka, Japan
TEL
06-6879-3857
Homepage URL
hamatea@kid.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Department of Comprehensive Kidney Disease Research
Institute
Department
Personal name
Funding Source
Organization
Grant for pathophysiological research conference in chronic kidney disease
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Molecular Physiological Chemistry Laboratory, Inc.
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
小尾クリニック
東香里病院
西診療所
あけぼのクリニック
双葉クリニック
兵庫県立西宮病院
橋中診療所
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 15 | 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
Completed
Date of protocol fixation
| 2014 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 14 | Day |
Last follow-up date
| 2016 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 11 | Day |
Last modified on
| 2016 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017152
| Research Plan | |
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| Registered date | File name |
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