UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective, randomized, open-label, blinded-endpoint trial to examine the effect of active vitamin D on cardiovascular events in hemodialysis patients: Japan Dialysis Active Vitamin D trial (J-DAVID)
Title of the study (Brief title)	Japan Dialysis Active Vitamin D trial (J-DAVID)
Region	Japan

Condition
Condition	Chronic kidney disease stage 5D
Classification by specialty	Cardiology Endocrinology and Metabolism Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine whether active vitamin D reduces the risk of cardiovascular events in hemodialysis patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	1) Fatal or nonfatal cardiovascular events (acute myocardial infarction, congestive heart failure, stroke, aortic dissection/rupture, amputation of ischemic limb, cardiac sudden death) 2) Coronary intervention (POBA, stenting) or bypass grafting 3) Lower limb artery intervention (POBA, stenting) or bypass grafting
Key secondary outcomes	All-cause mortality

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	oral alfacalcidol
Interventions/Control_2	No treatment with active vitamin D or analog
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	The subjects are those who fulfill the following four conditions; 1) Duration of dialysis is 90 days or longer, 2) 20 =< age =< 80 years, 3) No treatment with active vitamin D or analogs in preceding four weeks or longer, 4) Serum Ca =< 10.0 mg/dL and P =< 6.0 mg/dL and intact PTH =< 180 pg/mL
Key exclusion criteria	1) Myocardial infarction, stroke, aortic dissection/rupture, lower limb amputation in preceding 12 weeks, 2) Severe heart failure (NYHA class III or IV), 3) Respiratory failure (PaO2 < 60 mmHg or SpO2 < 90%), 4)Severe illness with life expectancy less than 1 year, 5) Liver dysfunction with AST or ALT elevation exceeding 3 x upper limit of normal, 6)Pregnant, lactating women or women who plan to be pregnant, 7) History of allergy to the test drug, 8) Participation to other intervention trails in the preceding 12 weeks, 9)Others who are judged inappropriate for the study by the physician
Target sample size	972

Research contact person
Name of lead principal investigator	Tetsuo Shoji
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Vascular Medicine
Address	1-4-3, Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL	06-6645-3930
Email	t-shoji@med.osaka-cu.ac.jp

Public contact
Name of contact person	Tetsuo Shoji
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Vascular Medicine
Address	1-4-3, Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL	06-6645-3930
Homepage URL	http://www.j-david.info/
Email	t-shoji@med.osaka-cu.ac.jp

Sponsor
Institute	J-DAVID Research Group
Institute
Department

Funding Source
Organization	The Kidney Foundation, Japan
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2008 Year 06 Month 19 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 02 Month 25 Day
Anticipated trial start date	2008 Year 07 Month 01 Day
Last follow-up date	2015 Year 04 Month 04 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2017 Year 01 Month 31 Day

Related information
URL releasing protocol	http://rrtjournal.biomedcentral.com/articles/10.1186/s41100-016-0029-z
Publication of results	Unpublished
URL releasing results
Results	Participant recruitment was started in June 2008, and the first one was registered and randomized in August 2008. We randomized 976 participants to the intervention group (alfacalcidol) or the control group (no VDRA) and followed up to 4 years. No significant difference was observed with the hazard ratio was 1.25 (95%CI, 0.94-1.67), P=0.127 for the primary composite cardiovascular endpoint.
Other related information	The results were presented at the 54th ERA-EDTA Congress in Madrid (June 4, 2017) as one of the late-breaking clinical trials, and also at the 62nd Annual Meeting of the Japanese Society for Dialysis Therapy in Yokohama (June 16, 2017). The final report was published on December 11, 2018 in JAMA. 2018;320(22):2325-2334. doi:10.1001/jama.2018.17749

Management information
Registered date	2008 Year 06 Month 17 Day
Last modified on	2019 Year 01 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001456