Management of Mineral and Bone Disease in Hemodialysis-Calcitriol vs. Paricalcitol (ECRIP)
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 Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
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|
- Percentage of patients in range for calcium during the 3 months after randomization and 3 months after cross-over. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- Percentage of patients in range for PTH during the 3 months after randomization and 3 months after cross-over. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- Percentage of patients in range for phosphorus during the 3 months after randomization and 3 months after cross-over. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- Amount of active vitamin D analog used during the first 3months and 6 months of the study. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Patients will be converted from paricalcitol to calcitriol according to published package inserts which describe a 10mcg:3mcg ratio.
3 times weekly
Other Name: Calcijex®
Active Comparator: Paricalcitol
Continuation of intravenous paricalcitol that patient was originally on at the time of recruitment.
3 times weekly
Other Name: Zemplar®
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01725113
|Contact: Candace D Grant, MD||(516)-663-0333 ext firstname.lastname@example.org|
|Contact: Shayan Shirazian, MD||(516)-663-0333 ext email@example.com|
|United States, New York|
|Winthrop University Hospital||Recruiting|
|Mineola, New York, United States, 11501|
|Principal Investigator:||Shayan Shirazian, MD||Winthrop University Hospital|