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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01382212
First received: June 24, 2011
Last updated: August 18, 2014
Last verified: August 2014

June 24, 2011
August 18, 2014
October 2011
June 2015   (final data collection date for primary outcome measure)
Hypercalcemia [ Time Frame: From Day 1 to week 12 ] [ Designated as safety issue: Yes ]
Incidence of hypercalcemia (two consecutive, post baseline corrected calcium measures greater than 10.2 mg/dL). This data will be gathered via blood draws.
Hypercalcemia [ Time Frame: Every 2 weeks during the 12 week dosing period, up to week 12 ] [ Designated as safety issue: Yes ]
Incidence of hypercalcemia (two consecutive, post baseline corrected calcium measures greater than 10.2 mg/dL). This data will be gathered via blood draws.
Complete list of historical versions of study NCT01382212 on ClinicalTrials.gov Archive Site
  • Intact parathyroid hormone [ Time Frame: From Day 1 to week 12 ] [ Designated as safety issue: No ]
    Proportion of subjects who achieve 2 consecutive intact parathyroid hormone values between 150 to 300 pg/mL (or greater than or equal to 30 percent reduction from baseline in intact parathyroid hormone).
  • Changes from baseline in chemistry and hematology lab variables [ Time Frame: During the 12 week dosing period, up to week 12 ] [ Designated as safety issue: Yes ]
  • Proportion of subjects experiencing adverse events [ Time Frame: From Day 1 to week 12 ] [ Designated as safety issue: Yes ]
  • Changes from baseline in electrocardiogram (ECG) [ Time Frame: From Day 1 to week 12 ] [ Designated as safety issue: Yes ]
  • Changes from baseline in vital signs [ Time Frame: From Day 1 to week 12 ] [ Designated as safety issue: Yes ]
  • Intact parathyroid hormone (iPTH) [ Time Frame: Every 2 weeks during the 12 week dosing period, up to week 12 ] [ Designated as safety issue: No ]
    Proportion of subjects who achieve 2 consecutive iPTH values between 150 to 300 pg/mL (or greater than or equal to 30% reduction from baseline in iPTH). This data will be gathered via blood draws.
  • Safety Measures [ Time Frame: During the 12 week dosing period, up to week 12 ] [ Designated as safety issue: Yes ]
    Safety to be assessed through adverse events, changes from baseline in chemistry and hematology lab variables, electrocardiogram (ECG), and changes from baseline in vital signs and physical examinations.
Not Provided
Not Provided
 
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
A Phase 3, Open-Label, Multicenter 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

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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • End-Stage Renal Disease
  • Secondary Hyperparathyroidism
Drug: paricalcitol
Capsules, open-label, single-arm
Other Name: Zemplar
Experimental: Paricalcitol
Open-label, active drug
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
12
September 2015
June 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject must be receiving peritoneal dialysis or hemodialysis 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 or 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
Both
10 Years to 16 Years
No
Contact: Kim Grabbe, MS 847-935-7838 Kim.Grabbe@abbvie.com
Contact: Emily Kunka, BS 847-937-7312 emily.kunka@abbvie.com
United States,   Germany,   Portugal,   United Kingdom
 
NCT01382212
M11-612, 2013-002610-13
No
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Ann Eldred, MD AbbVie
AbbVie
August 2014

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