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

Phase 4

Terminated

• Conditions: Kidney Failure; Secondary Hyperparathyroidism; Hyperphosphatemia; Hypercalcemia
• Interventions: Drug: Calcitriol; Drug: Paricalcitol

• Registration Number: NCT01725113
• Lead Sponsor: Winthrop University Hospital

Brief 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.

Detailed Description

Active vitamin D analogs have been the mainstay of treatment for patients on hemodialysis with mineral and bone disease (MBD) for the past decade. Intravenous calcitriol is an active vitamin D analog which is nearly identical to natural 1, 25 Vitamin D3. Calcitriol results from the hydroxylation of previtamin D3 in the liver and kidney. Paricalcitol, 19-nor-1 , 25-dihydroxyvitamin D2, is a newer agent vitamin D analog. This agent is believed to have an effect more specific to the parathyroid gland, and less specific to absorption of calcium and phosphorus from the gut. Although both formulations appear equally effective in suppressing parathyroid hormone (PTH), studies have suggested a greater calcemic effect with intravenous calcitriol as compared to paricalcitol (1). Due to this, paricalcitol is the predominant active vitamin D analog used in hemodialysis patients in the United States. Two recent changes in the management of hemodialysis patients will likely reduce the amount of active vitamin D analogs used in the near future: the liberalization of PTH goals according to international guidelines, (2) and the implementation of bundled payments for dialysis by Medicare. These changes challenge previous studies that have analyzed the safety and efficacy of these medications. The purpose of this prospective, randomized, cross-over study will be to determine whether calcitriol is as safe and effective as paricalcitol in the treatment of MBD in hemodialysis patients using the revised KDIGO parathyroid hormone targets. Our hypothesis is that calcitriol will be as equally safe and effective as paricalcitol in the treatment of MBD in hemodialysis patients.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-07
• Study First Submitted QC: 2012-11-09
• Study First Posted: 2012-11-12
• Primary Completion: 2013-12
• Study Completion: 2015-10
• Results First Submitted: 2023-09-19
• Status Verified: 2023-10
• Results First Submitted QC: 2023-10-31
• Last Update Submitted: 2023-10-31
• Results First Posted: 2023-11-07
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Calcitriol, then Paricalcitol	Calcitriol	Patients randomized to an active vitamin D treatment protocol based on IV calcitriol. After 14 weeks, patients cross-over to an active vitamin D protocol based on IV paricalcitol for 14 weeks.
Paricalcitol, then Calcitriol	Paricalcitol	Patients randomized to an active vitamin D treatment protocol based on IV paricalcitol. After 14 weeks, patients cross-over to an active vitamin D protocol based on IV calcitriol for 14 weeks.
Calcitriol, then Paricalcitol	Paricalcitol	Patients randomized to an active vitamin D treatment protocol based on IV calcitriol. After 14 weeks, patients cross-over to an active vitamin D protocol based on IV paricalcitol for 14 weeks.
Paricalcitol, then Calcitriol	Calcitriol	Patients randomized to an active vitamin D treatment protocol based on IV paricalcitol. After 14 weeks, patients cross-over to an active vitamin D protocol based on IV calcitriol for 14 weeks.

Primary Outcome Measures

Name	Time	Method
Calcium Levels at Month 3 Post Calcitriol Treatment Initiation	Up to Month 6
Calcium Levels at Month 3 Post Paricalcitol Treatment Initiation	Up to Month 6

Secondary Outcome Measures

Name	Time	Method
Phosphorus Levels at Month 3 Post Paricalcitol Initiation	Up to Month 6
PTH Levels at Month 3 Post Paricalcitol Treatment Initiation	Up to Month 6
Phosphorus Levels at Month 3 Post Calcitriol Initiation	Up to Month 6
Amount of Active Vitamin D Analog Used Through Month 3 Post Calcitriol Initiation	Up to Month 6
Amount of Active Vitamin D Analog Used Through Month 3 Post Paricalcitol Initiation	Up to Month 6
PTH Levels at Month 3 Post Calcitriol Treatment Initiation	Up to Month 6

Trial Locations

Locations (1)

Winthrop University Hospital; 🇺🇸 Mineola, New York, United States