Management of Mineral and Bone Disease in Hemodialysis-Calcitriol vs. Paricalcitol (ECRIP)
Primary Purpose
Kidney Failure, Secondary Hyperparathyroidism, Hyperphosphatemia
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Calcitriol
Paricalcitol
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Failure
Eligibility 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:
- age greater than 18
- active malignancy
- expected survival greater than 6 months
- high likelihood of renal transplant during the study period.
- Low calcium bath
- prior parathyroidectomy
- use of calcimimetics
Sites / Locations
- Winthrop University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Calcitriol
Paricalcitol
Arm Description
Patients will be converted from paricalcitol to calcitriol according to published package inserts which describe a 10mcg:3mcg ratio.
Continuation of intravenous paricalcitol that patient was originally on at the time of recruitment.
Outcomes
Primary Outcome Measures
Percentage of patients in range for calcium during the 3 months after randomization and 3 months after cross-over.
Secondary Outcome Measures
Percentage of patients in range for PTH during the 3 months after randomization and 3 months after cross-over.
Percentage of patients in range for phosphorus during the 3 months after randomization and 3 months after cross-over.
Amount of active vitamin D analog used during the first 3months and 6 months of the study.
Full Information
NCT ID
NCT01725113
First Posted
November 7, 2012
Last Updated
January 11, 2016
Sponsor
Winthrop University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01725113
Brief Title
Management of Mineral and Bone Disease in Hemodialysis-Calcitriol vs. Paricalcitol
Acronym
ECRIP
Official Title
A Randomized, Prospective, Cross-Over Study of Calcitriol vs. Paricalcitol in the Treatment of Mineral and Bone Disease in Hemodialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Why Stopped
Nationwide shortage of study meds in 2013 loss of funding & competing studies
Study Start Date
November 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Winthrop University Hospital
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Secondary Hyperparathyroidism, Hyperphosphatemia, Hypercalcemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Calcitriol
Arm Type
Experimental
Arm Description
Patients will be converted from paricalcitol to calcitriol according to published package inserts which describe a 10mcg:3mcg ratio.
Arm Title
Paricalcitol
Arm Type
Active Comparator
Arm Description
Continuation of intravenous paricalcitol that patient was originally on at the time of recruitment.
Intervention Type
Drug
Intervention Name(s)
Calcitriol
Other Intervention Name(s)
Calcijex®
Intervention Description
3 times weekly
Intervention Type
Drug
Intervention Name(s)
Paricalcitol
Other Intervention Name(s)
Zemplar®
Intervention Description
3 times weekly
Primary Outcome Measure Information:
Title
Percentage of patients in range for calcium during the 3 months after randomization and 3 months after cross-over.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Percentage of patients in range for PTH during the 3 months after randomization and 3 months after cross-over.
Time Frame
3 months
Title
Percentage of patients in range for phosphorus during the 3 months after randomization and 3 months after cross-over.
Time Frame
3 months
Title
Amount of active vitamin D analog used during the first 3months and 6 months of the study.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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:
age greater than 18
active malignancy
expected survival greater than 6 months
high likelihood of renal transplant during the study period.
Low calcium bath
prior parathyroidectomy
use of calcimimetics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shayan Shirazian, MD
Organizational Affiliation
Winthrop University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Management of Mineral and Bone Disease in Hemodialysis-Calcitriol vs. Paricalcitol
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