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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01725113
Other study ID # 12027
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date November 2012
Est. completion date October 2015

Study information

Verified date October 2023
Source Winthrop University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 16
Est. completion date October 2015
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
Calcitriol
3 times weekly
Paricalcitol
3 times weekly

Locations

Country Name City State
United States Winthrop University Hospital Mineola New York

Sponsors (1)

Lead Sponsor Collaborator
Winthrop University Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Calcium Levels at Month 3 Post Calcitriol Treatment Initiation Up to Month 6
Primary Calcium Levels at Month 3 Post Paricalcitol Treatment Initiation Up to Month 6
Secondary PTH Levels at Month 3 Post Calcitriol Treatment Initiation Up to Month 6
Secondary PTH Levels at Month 3 Post Paricalcitol Treatment Initiation Up to Month 6
Secondary Phosphorus Levels at Month 3 Post Calcitriol Initiation Up to Month 6
Secondary Phosphorus Levels at Month 3 Post Paricalcitol Initiation Up to Month 6
Secondary Amount of Active Vitamin D Analog Used Through Month 3 Post Calcitriol Initiation Up to Month 6
Secondary Amount of Active Vitamin D Analog Used Through Month 3 Post Paricalcitol Initiation Up to Month 6
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