Recruitment

Recruitment Status
Completed

Inclusion Criteria

Patients with end-stage renal disease receiving thrice-weekly maintenance hemodialysis
On treatment with erythropoietin stimulating agent
With written informed consent
Patients with end-stage renal disease receiving thrice-weekly maintenance hemodialysis
On treatment with erythropoietin stimulating agent
With written informed consent

Exclusion Criteria

On supplementation with native vitamin D
Hypercalcemia (>=10.5 mg/dL of corrected serum calcium)
On treatment with epoetin beta pegol as ESA
...
On supplementation with native vitamin D
Hypercalcemia (>=10.5 mg/dL of corrected serum calcium)
On treatment with epoetin beta pegol as ESA
On treatment with intravenous iron agents
Judged as ineligible to the randomized study by the investigators

Summary

Conditions
  • Anemia
  • Bone Diseases, Metabolic
  • Kidney Failure Chronic
  • Vitamin D Deficiency
  • Kidney Failure, Chronic
Type
Interventional
Phase
Phase 4
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 20 years and 125 years
Gender
Both males and females

Description

There are 4 arms in this study: (1) Thrice-weekly cholecalciferol supplementation (3,000 IU), (2) Monthly cholecalciferol supplementation (equivalent to 9,000/week), (3) Thrice-weekly placebo, and (4) Monthly placebo. The primary analyses will be done regarding 2 cholecalciferol groups and 2 placebo...

There are 4 arms in this study: (1) Thrice-weekly cholecalciferol supplementation (3,000 IU), (2) Monthly cholecalciferol supplementation (equivalent to 9,000/week), (3) Thrice-weekly placebo, and (4) Monthly placebo. The primary analyses will be done regarding 2 cholecalciferol groups and 2 placebo groups as one group each, and we will evaluate the effect of cholecalciferol regardless of the supplementation regimen. As the secondary analyses, we will examine if there is any difference between thrice-weekly and once-monthly supplementation regimen.

Inclusion Criteria

Patients with end-stage renal disease receiving thrice-weekly maintenance hemodialysis
On treatment with erythropoietin stimulating agent
With written informed consent
Patients with end-stage renal disease receiving thrice-weekly maintenance hemodialysis
On treatment with erythropoietin stimulating agent
With written informed consent

Exclusion Criteria

On supplementation with native vitamin D
Hypercalcemia (>=10.5 mg/dL of corrected serum calcium)
On treatment with epoetin beta pegol as ESA
...
On supplementation with native vitamin D
Hypercalcemia (>=10.5 mg/dL of corrected serum calcium)
On treatment with epoetin beta pegol as ESA
On treatment with intravenous iron agents
Judged as ineligible to the randomized study by the investigators

Locations

Osaka, 543-0052
Suita, Osaka, 565-0871
Osaka, 559-0013
Osaka, 552-0007
Hirakata, Osaka, 573-0075
...
Osaka, 543-0052
Suita, Osaka, 565-0871
Osaka, 559-0013
Osaka, 552-0007
Hirakata, Osaka, 573-0075
Nishinomiya, Hyogo, 662-0918
Kumamoto, 861-4112

Tracking Information

NCT #
NCT02214563
Collaborators
  • The Japan Kidney Foundation
  • Molecular Physiological Chemistry Laboratory, Inc.
  • Obi clinic
  • Higashikouri Hospital
  • Nishi clinic
  • Futaba clinic
  • Akebono clinic
Investigators
Study Chair: Yoshiharu Tsubakihara, MD, PhD Department of Comprehensive Kidney Disease Research, Osaka University Graduate School of Medicine