UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Cholecalciferol Supplementation for Anemia and Mineral and Bone Disorder in Hemodialysis Patients (CHAMBER): A Multicenter, Double-blind, Randomized, Placebo-controlled Trial
Title of the study (Brief title)	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	Takayuki Hamano
Organization	Osaka University Graduate School of Medicine
Division name	Department of Comprehensive Kidney Disease Research
Address	2-2, Yamada-oka, Suita, Osaka, Japan
TEL	06-6879-3857
Email	tsubakihara@kid.med.osaka-u.ac.jp

Public contact
Name of contact person	Takayuki Hamano
Organization	Osaka University Graduate School of Medicine
Division name	Department of Comprehensive Kidney Disease Research
Address	2-2, Yamada-oka, Suita, Osaka, Japan
TEL	06-6879-3857
Homepage URL
Email	hamatea@kid.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University Graduate School of Medicine Department of Comprehensive Kidney Disease Research
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 08 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017152