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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

Sponsored by Abbott

Phase Quota
Phase 3

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 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.

Study Start Date: October 2011

Estimated Completion Date: April 2015

Specialties: Pediatrics: Clinical Pharmacology,Nephrology/Urology,Pediatric Endocrinology Endocrinology: Peds Endocrinology,Pharmacology/kinetics,Thyroid/Parathyroid Nephrology: Chronic Dz/Renal Failure,Dialysis,Endocrinology,Peds Nephrology,Pharmacology/kinetics Pharmacy: Drug Trials

Interventions

  • Drug: Paricalcitol
  • Drug: paricalcitol

Inclusion criteria

  • Subject must be receiving peritoneal dialysis for at least 3 months prior to Screening
  • Male or female subject between 10 and 16 years of age, inclusive at the time of Screening
  • Subject is currently being 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 must meet the following laboratory criteria prior to enrollment:
    • A corrected calcium value greater than or equal to 8.4 and less than or equal to 10.2 mg/dL
    • A phosphorus value less than or equal to 6.5 mg/dL
    • An intact parathyroid hormone value greater than 300 pg/mL and less than or equal to 2000 pg/mL

Exclusion criteria

  • Subject is expected or scheduled to receive a living donor kidney transplant within 3 months of Screening or is a kidney transplant patient requiring full immunosuppressant therapy
  • Subject is expected to stop peritoneal dialysis within 4 months of Screening (per investigator discretion)
  • Subject is expected to transfer to chronic hemodialysis within 4 months of Screening (per investigator discretion)
  • Subject has had a parathyroidectomy within 12 weeks prior to Screening
  • Subject has had symptomatic or significant hypocalcemia requiring VDR Activator therapy (i.e., calcitriol, paricalcitol, or doxercalciferol) within 2 months prior to Screening
  • Subject is taking maintenance calcitonin, bisphosphonates, glucocorticoids in an equivalent dose of greater than 5 mg prednisone daily, or other drugs known to affect calcium or bone metabolism within 4 to 8 weeks prior to Dosing
  • Subject is receiving cinacalcet at the time of Screening

Study Locations And Contact Information

  • Site Reference IDInvestigator 102115, Oklahoma City Oklahoma
  • Site Reference IDInvestigator 85893, San Antonio Texas
  • Site Reference IDInvestigator 53324, Atlanta Georgia
  • Site Reference IDInvestigator 53326, Dallas Texas
  • Site Reference IDInvestigator 48565, Los Angeles California
  • Site Reference IDInvestigator 48555, St. Louis Missouri
  • Site Reference IDInvestigator 48552, Chicago Illinois
  • Site Reference IDInvestigator 114135, Essen
  • Site Reference IDInvestigator 48570, Kansas City Missouri
  • Site Reference IDInvestigator 48566, Salt Lake City Utah
  • Site Reference IDInvestigator 102275, Louisville Kentucky
  • Site Reference IDInvestigator 102115, Oklahoma City Oklahoma
  • Site Reference IDInvestigator 112995, Lisbon
  • Site Reference IDInvestigator 48565, Los Angeles California
  • Site Reference IDInvestigator 117995, Manchester
  • Site Reference IDInvestigator 77456, Cincinnati Ohio
  • Site Reference IDInvestigator 116555, Milwaukee Wisconsin
  • Site Reference IDInvestigator 55342, Los Angeles California
  • Site Reference IDInvestigator 114135, Essen
  • Site Reference IDInvestigator 77456, Cincinnati Ohio
  • Site Reference IDInvestigator 48552, Chicago Illinois
  • Site Reference IDInvestigator 85893, San Antonio Texas
  • Site Reference IDInvestigator 48566, Salt Lake City Utah
  • Site Reference IDInvestigator 48570, Kansas City Missouri
  • Site Reference IDInvestigator 79955, Birmingham Alabama
  • Site Reference IDInvestigator 117995, Manchester
  • Site Reference IDInvestigator 102275, Louisville Kentucky
  • Site Reference IDInvestigator 55342, Los Angeles California
  • Site Reference IDInvestigator 112995, Lisbon
  • Site Reference IDInvestigator 95275, Greenville North Carolina

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