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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

This study has been completed.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) ) Identifier:
First received: June 24, 2011
Last updated: May 20, 2016
Last verified: May 2016
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 ]

Enrollment: 13
Study Start Date: October 2011
Study Completion Date: April 2015
Primary Completion Date: April 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


Ages Eligible for Study:   10 Years to 16 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 identifier: NCT01382212

United States, Alabama
Site Reference ID/Investigator# 79955
Birmingham, Alabama, United States, 35255
United States, California
Site Reference ID/Investigator# 55342
Los Angeles, California, United States, 90027
Site Reference ID/Investigator# 48565
Los Angeles, California, United States, 90095-1752
United States, Georgia
Site Reference ID/Investigator# 53324
Atlanta, Georgia, United States, 30322
United States, Illinois
Site Reference ID/Investigator# 48552
Chicago, Illinois, United States, 60611
United States, Kentucky
Site Reference ID/Investigator# 102275
Louisville, Kentucky, United States, 40202
United States, Missouri
Site Reference ID/Investigator# 48570
Kansas City, Missouri, United States, 64108
Site Reference ID/Investigator# 48555
St. Louis, Missouri, United States, 63110
United States, North Carolina
Site Reference ID/Investigator# 95275
Greenville, North Carolina, United States, 27834
United States, Ohio
Site Reference ID/Investigator# 77456
Cincinnati, Ohio, United States, 45229
United States, Oklahoma
Site Reference ID/Investigator# 102115
Oklahoma City, Oklahoma, United States, 73104
United States, Texas
Site Reference ID/Investigator# 53326
Dallas, Texas, United States, 75390
Site Reference ID/Investigator# 85893
San Antonio, Texas, United States, 78229
United States, Utah
Site Reference ID/Investigator# 48566
Salt Lake City, Utah, United States, 84113
United States, Wisconsin
Site Reference ID/Investigator# 116555
Milwaukee, Wisconsin, United States, 53226
Site Reference ID/Investigator# 114135
Essen, Germany, 45147
Site Reference ID/Investigator# 112995
Lisbon, Portugal, 1169-045
United Kingdom
Site Reference ID/Investigator# 117995
Manchester, United Kingdom, M13 9WL
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Study Director: Ann Eldred, MD AbbVie
  More Information

Additional Information:
Responsible Party: AbbVie (prior sponsor, Abbott) Identifier: NCT01382212     History of Changes
Other Study ID Numbers: M11-612  2013-002610-13 
Study First Received: June 24, 2011
Last Updated: May 20, 2016
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:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Hyperparathyroidism, Secondary
Urologic Diseases
Renal Insufficiency
Parathyroid Diseases
Endocrine System Diseases
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on October 25, 2016