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
  Purpose

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.


Condition Intervention Phase
End-Stage Renal Disease
Secondary Hyperparathyroidism
Drug: paricalcitol
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 12
Study Start Date: October 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paricalcitol
Open-label, active drug
Drug: paricalcitol
Capsules, open-label, single-arm
Other Name: Zemplar

  Eligibility

Ages Eligible for Study:   10 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01382212

Contacts
Contact: Kim Grabbe, MS 847-935-7838 Kim.Grabbe@abbvie.com
Contact: Emily Kunka, BS 847-937-7312 emily.kunka@abbvie.com

  Show 19 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Ann Eldred, MD AbbVie
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01382212     History of Changes
Other Study ID Numbers: M11-612, 2013-002610-13
Study First Received: June 24, 2011
Last Updated: August 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AbbVie:
Evaluate safety through the evaluation of the incidence of hypercalcemia in pediatric subjects

Additional relevant MeSH terms:
Parathyroid Diseases
Hyperparathyroidism
Hyperparathyroidism, Secondary
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Endocrine System Diseases
Renal Insufficiency
Urologic Diseases
Ergocalciferols
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Vitamins

ClinicalTrials.gov processed this record on October 20, 2014