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

Sponsor

Winthrop University Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT01725113

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Failure Secondary Hyperparathyroidism Hyperphosphatemia Hypercalcemia	Drug: Calcitriol Drug: Paricalcitol	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

11 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2012

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Calcitriol Patients will be converted from paricalcitol to calcitriol according to published package inserts which describe a 10mcg:3mcg ratio.	Drug: Calcitriol 3 times weekly Other Names: Calcijex®
Active Comparator: Paricalcitol Continuation of intravenous paricalcitol that patient was originally on at the time of recruitment.	Drug: Paricalcitol 3 times weekly Other Names: Zemplar®

Arm

Intervention/Treatment

Experimental: Calcitriol

Patients will be converted from paricalcitol to calcitriol according to published package inserts which describe a 10mcg:3mcg ratio.

Drug: Calcitriol

3 times weekly

Other Names:

Calcijex®

Active Comparator: Paricalcitol

Continuation of intravenous paricalcitol that patient was originally on at the time of recruitment.

Drug: Paricalcitol

3 times weekly

Other Names:

Zemplar®

Outcome Measures

Primary Outcome Measures

Percentage of patients in range for calcium during the 3 months after randomization and 3 months after cross-over. [3 months]

Secondary Outcome Measures

Percentage of patients in range for PTH during the 3 months after randomization and 3 months after cross-over. [3 months]
Percentage of patients in range for phosphorus during the 3 months after randomization and 3 months after cross-over. [3 months]
Amount of active vitamin D analog used during the first 3months and 6 months of the study. [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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