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

This study is currently recruiting participants.
Verified November 2012 by Winthrop University Hospital
Sponsor:
Information provided by (Responsible Party):
Winthrop University Hospital
ClinicalTrials.gov Identifier:
NCT01725113
First received: November 7, 2012
Last updated: November 9, 2012
Last verified: November 2012

November 7, 2012
November 9, 2012
November 2012
June 2013   (final data collection date for 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01725113 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Management of Mineral and Bone Disease in Hemodialysis-Calcitriol vs. Paricalcitol
A Randomized, Prospective, Cross-Over Study of Calcitriol vs. Paricalcitol in the Treatment of Mineral and Bone Disease in Hemodialysis Patients

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Kidney Failure
  • Secondary Hyperparathyroidism
  • Hyperphosphatemia
  • Hypercalcemia
  • Drug: Calcitriol
    3 times weekly
    Other Name: Calcijex®
  • Drug: Paricalcitol
    3 times weekly
    Other Name: Zemplar®
  • Experimental: Calcitriol
    Patients will be converted from paricalcitol to calcitriol according to published package inserts which describe a 10mcg:3mcg ratio.
    Intervention: Drug: Calcitriol
  • Active Comparator: Paricalcitol
    Continuation of intravenous paricalcitol that patient was originally on at the time of recruitment.
    Intervention: Drug: Paricalcitol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Candace D Grant, MD (516)-663-0333 ext 9054 cgrant@winthrop.org
Contact: Shayan Shirazian, MD (516)-663-0333 ext 2170 sshirazian@winthrop.org
United States
 
NCT01725113
12027
No
Winthrop University Hospital
Winthrop University Hospital
Not Provided
Principal Investigator: Shayan Shirazian, MD Winthrop University Hospital
Winthrop University Hospital
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP