UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001194 |
|---|---|
| Receipt number | R000001456 |
| Scientific Title | 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) |
| Date of disclosure of the study information | 2008/06/19 |
| Last modified on | 2019/01/03 22:19:41 |
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Basic information
Public title
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)
Acronym
Japan Dialysis Active Vitamin D trial (J-DAVID)
Scientific Title
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)
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Tetsuo Shoji |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Vascular Medicine
Zip code
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL
06-6645-3930
t-shoji@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuo Shoji |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Vascular Medicine
Zip code
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL
06-6645-3930
Homepage URL
http://www.j-david.info/
t-shoji@med.osaka-cu.ac.jp
Sponsor or person
Institute
J-DAVID Research Group
Institute
Department
Personal name
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)
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
| 2008 | Year | 06 | Month | 19 | Day |
Related information
URL releasing protocol
http://rrtjournal.biomedcentral.com/articles/10.1186/s41100-016-0029-z
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
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.
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 | 02 | Month | 25 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001456
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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