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

This study is currently recruiting participants. (see Contacts and Locations)
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
  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.


Condition Intervention Phase
Kidney Failure
Secondary Hyperparathyroidism
Hyperphosphatemia
Hypercalcemia
Drug: Calcitriol
Drug: Paricalcitol
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Winthrop University Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: November 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Calcijex®
Active Comparator: Paricalcitol
Continuation of intravenous paricalcitol that patient was originally on at the time of recruitment.
Drug: Paricalcitol
3 times weekly
Other Name: Zemplar®

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01725113

Contacts
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

Locations
United States, New York
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Sponsors and Collaborators
Winthrop University Hospital
Investigators
Principal Investigator: Shayan Shirazian, MD Winthrop University Hospital
  More Information

No publications provided

Responsible Party: Winthrop University Hospital
ClinicalTrials.gov Identifier: NCT01725113     History of Changes
Other Study ID Numbers: 12027
Study First Received: November 7, 2012
Last Updated: November 9, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Water-Electrolyte Imbalance
Bone Diseases
Hypercalcemia
Hyperparathyroidism
Hyperparathyroidism, Secondary
Renal Insufficiency
Hyperphosphatemia
Musculoskeletal Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Parathyroid Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases
Phosphorus Metabolism Disorders
Calcitriol
Ergocalciferols
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 26, 2014