Cholecalciferol Supplementation for Anemia and Mineral and Bone Disorder in Hemodialysis Patients (CHAMBER): A Multicenter, Double-blind, Randomized, Placebo-controlled Trial
Phase 4
- Conditions
- End-stage renal disease requiring hemodialysis
- Registration Number
- JPRN-UMIN000014819
- Lead Sponsor
- Osaka University Graduate School of Medicine Department of Comprehensive Kidney Disease Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Serum hepcidin-25 concentrations at day 3 and the 3rd month
- Secondary Outcome Measures
Name Time Method 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