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Mineola, New York 11501

  • Hypercalcemia

Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

12027


NCT ID:

NCT01725113


Secondary ID:


Study Acronym:

ECRIP


Brief Title:

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


Official Title:

A Randomized, Prospective, Cross-Over Study of Calcitriol vs. Paricalcitol in the Treatment of Mineral and Bone Disease in Hemodialysis Patients


Overall Status:

Terminated


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Winthrop University Hospital


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

Nationwide shortage of study meds in 2013 lo


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

11


Enrollment Type:

Actual


Overall Contact Information

Official Name:Shayan Shirazian, MD
Principal Investigator
Winthrop University Hospital

Study Dates

Start Date:November 2012
Completion Date:October 2015
Completion Type:Actual
Primary Completion Date:December 2013
Primary Completion Type:Actual
Verification Date:January 2016
Last Changed Date:January 11, 2016
First Received Date:November 7, 2012

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Amount of active vitamin D analog used during the first 3months and 6 months of the study.
Time Frame:3 months
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Percentage of patients in range for phosphorus during the 3 months after randomization and 3 months after cross-over.
Time Frame:3 months
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Percentage of patients in range for PTH during the 3 months after randomization and 3 months after cross-over.
Time Frame:3 months
Safety Issues:True
Outcome Type:Primary Outcome
Measure:Percentage of patients in range for calcium during the 3 months after randomization and 3 months after cross-over.
Time Frame:3 months
Safety Issues:True

Study Interventions

Intervention Type:Drug
Name:Paricalcitol
Description:3 times weekly
Arm Name:Paricalcitol
Other Name:Zemplar®
Intervention Type:Drug
Name:Calcitriol
Description:3 times weekly
Arm Name:Calcitriol
Other Name:Calcijex®

Study Arms

Study Arm Type:Active Comparator
Arm Name:Paricalcitol
Description:Continuation of intravenous paricalcitol that patient was originally on at the time of recruitment.
Study Arm Type:Experimental
Arm Name:Calcitriol
Description:Patients will be converted from paricalcitol to calcitriol according to published package inserts which describe a 10mcg:3mcg ratio.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Winthrop University Hospital

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 04, 2021

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