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)

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) - Japan Dialysis Active Vitamin D trial (J-DAVID)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001194

Enrollment

972

Registered

2008-06-19

Start date

2008-07-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic kidney disease stage 5D

Interventions

oral alfacalcidol No treatment with active vitamin D or analog

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Secondary

Measure	Time frame
All-cause mortality	—

Countries

Japan

Contacts

Public ContactTetsuo Shoji

Osaka City University Graduate School of Medicine Department of Vascular Medicine

t-shoji@med.osaka-cu.ac.jp06-6645-3930

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026