A Study to Evaluate the Safety of Paricalcitol Capsules in Pediatric Subjects Ages 10 to 16 With Stage 5 Chronic Kidney Disease Receiving Peritoneal Dialysis or Hemodialysis

Last updated: June 1, 2018
Sponsor: AbbVie (prior sponsor, Abbott)
Overall Status: Completed

Phase

3

Condition

Hyperparathyroidism

Renal Failure

Kidney Disease

Treatment

N/A

Clinical Study ID

NCT01382212
M11-612
2013-002610-13
  • Ages 10-16
  • All Genders

Study Summary

The objective is to evaluate the safety of paricalcitol capsules in pediatric subjects, ages 10 to 16 years old, with Stage 5 chronic kidney disease (kidney failure) receiving peritoneal dialysis or hemodialysis and being treated for secondary hyperparathyroidism. Subjects will be in the dosing period of the study for 12 weeks in order to evaluate the incidence of hypercalcemia (high calcium levels in blood). Approximately 12 subjects will be enrolled and all 12 will receive paricalcitol capsules.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject must be receiving peritoneal dialysis or hemodialysis for at least 3 monthsprior to Screening

  • Subject is currently being diagnosed and/or treated for secondary hyperparathyroidism

  • For entry into the Dosing Period (for subjects that are naïve to Vitamin D Receptor [VDR] Activators or those who have completed a 2 to 12 week washout), the subject mustmeet the following laboratory criteria prior to enrollment:

  • A corrected calcium value ≥ 8.2 and ≤ 10.4 mg/dL

  • A phosphorus value ≤ 6.5 mg/dL

  • An intact parathyroid hormone (iPTH) value > 300 pg/mL and less ≤ 2000 pg/mL

Exclusion

Exclusion Criteria:

  • Subject is expected or scheduled to receive a living donor kidney transplant within 3months of Screening or is a kidney transplant patient requiring full immunosuppressanttherapy

  • Subject is expected to stop peritoneal dialysis or hemodialysis within 4 months ofScreening (per investigator discretion)

  • Subject has had a parathyroidectomy within 12 weeks prior to Screening

  • Subject has had symptomatic or significant hypocalcemia requiring VDR Activatortherapy (i.e., calcitriol, paricalcitol, or doxercalciferol) within 2 months prior toScreening

  • Subject is taking maintenance calcitonin, bisphosphonates, glucocorticoids in anequivalent dose of greater than 5 mg prednisone daily, or other drugs known to affectcalcium or bone metabolism within 4 to 8 weeks prior to Dosing

  • Subject is receiving cinacalcet at the time of Screening

Study Design

Total Participants: 13
Study Start date:
October 01, 2011
Estimated Completion Date:
April 30, 2015

Connect with a study center

  • Site Reference ID/Investigator# 114135

    Essen, 45147
    Germany

    Site Not Available

  • Site Reference ID/Investigator# 112995

    Lisbon, 1169-045
    Portugal

    Site Not Available

  • Site Reference ID/Investigator# 117995

    Manchester, M13 9WL
    United Kingdom

    Site Not Available

  • Site Reference ID/Investigator# 79955

    Birmingham, Alabama 35255
    United States

    Site Not Available

  • Site Reference ID/Investigator# 48565

    Los Angeles, California 90095-1752
    United States

    Site Not Available

  • Site Reference ID/Investigator# 48560

    Miami, Florida 33155-4078
    United States

    Site Not Available

  • Site Reference ID/Investigator# 53324

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Site Reference ID/Investigator# 48552

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Site Reference ID/Investigator# 102275

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Site Reference ID/Investigator# 48570

    Kansas City, Missouri 64108
    United States

    Site Not Available

  • Site Reference ID/Investigator# 48555

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • Site Reference ID/Investigator# 48564

    Livingston, New Jersey 07039
    United States

    Site Not Available

  • Site Reference ID/Investigator# 95275

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • Site Reference ID/Investigator# 77456

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • Site Reference ID/Investigator# 102115

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Site Reference ID/Investigator# 53326

    Dallas, Texas 75390
    United States

    Site Not Available

  • Site Reference ID/Investigator# 85893

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Site Reference ID/Investigator# 48566

    Salt Lake City, Utah 84113
    United States

    Site Not Available

  • Site Reference ID/Investigator# 116555

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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