Management of Mineral and Bone Disease in Hemodialysis-Calcitriol vs. Paricalcitol

• Status: Terminated
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this non-inferiority study is to compare the safety and effectiveness of a mineral and bone disease treatment protocol based on calcitriol to one based on paricalcitol in hemodialysis patients using revised Kidney Disease: Improving Global Outcomes (KDIGO) parathyroid hormone targets.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Winthrop University Hospital
• Treatments: Calcitriol; Ergocalciferols

Criteria

Inclusion Criteria:

• All subjects will have been treated for at least three months on hemodialysis with IV paricalcitol. These subjects must have a most recent calcium level within the normal range, most recent phosphorus level < 8 mg/dL and a most recent PTH between 130-585 pg/mL

Exclusion Criteria:

Patients will be excluded if:

1. age greater than 18

2. active malignancy

3. expected survival greater than 6 months

4. high likelihood of renal transplant during the study period.

5. Low calcium bath

6. prior parathyroidectomy

7. use of calcimimetics