TerminatedPhase 4

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

Stopped: Nationwide shortage of study meds in 2013 loss of funding \& competing studies

United States16 participantsStarted 2012-11

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Exclusion criteria

✕. age greater than 18
✕. active malignancy
✕. expected survival greater than 6 months
✕. high likelihood of renal transplant during the study period.
✕. Low calcium bath
✕. prior parathyroidectomy
✕. use of calcimimetics

What they're measuring

Calcium Levels at Month 3 Post Calcitriol Treatment Initiation

Timeframe: Up to Month 6

Calcium Levels at Month 3 Post Paricalcitol Treatment Initiation

Timeframe: Up to Month 6

Trial details

NCT IDNCT01725113

SponsorWinthrop University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-12

Results submitted2023-09-19

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