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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01725113
Recruitment Status : Terminated (Nationwide shortage of study meds in 2013 loss of funding & competing studies)
First Posted : November 12, 2012
Last Update Posted : January 12, 2016
Information provided by (Responsible Party):
Winthrop University Hospital

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.

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Study Type : Interventional  (Clinical Trial)
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 : November 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

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 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®

Primary Outcome Measures :
  1. 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 Measures :
  1. Percentage of patients in range for PTH during the 3 months after randomization and 3 months after cross-over. [ Time Frame: 3 months ]
  2. Percentage of patients in range for phosphorus during the 3 months after randomization and 3 months after cross-over. [ Time Frame: 3 months ]
  3. Amount of active vitamin D analog used during the first 3months and 6 months of the study. [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01725113

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United States, New York
Winthrop University Hospital
Mineola, New York, United States, 11501
Sponsors and Collaborators
Winthrop University Hospital
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Principal Investigator: Shayan Shirazian, MD Winthrop University Hospital

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Responsible Party: Winthrop University Hospital Identifier: NCT01725113     History of Changes
Other Study ID Numbers: 12027
First Posted: November 12, 2012    Key Record Dates
Last Update Posted: January 12, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Bone Diseases
Renal Insufficiency
Hyperparathyroidism, Secondary
Parathyroid Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases
Musculoskeletal Diseases
Phosphorus Metabolism Disorders
Metabolic Diseases
Calcium Metabolism Disorders
Water-Electrolyte Imbalance
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Growth Substances
Bone Density Conservation Agents