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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.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01382212
First received: June 24, 2011
Last updated: November 8, 2016
Last verified: November 2016
  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:
  • Percentage of Subjects With Hypercalcemia [ Time Frame: Day 1 to Week 12 ] [ Designated as safety issue: Yes ]
    The percentage of subjects with hypercalcemia, defined as at least 2 consecutive post-baseline corrected calcium values > 10.2 mg/dL (2.55 mmol/L).


Secondary Outcome Measures:
  • Percentage of Subjects With 2 Consecutive Intact Parathyroid Hormone (iPTH)/120 Between 150 and 300 pg/mL [ Time Frame: Baseline (last measurement collected prior to the first dose) to Week 12 ] [ Designated as safety issue: No ]
  • Percentage of Subjects With 2 Consecutive iPTH Reductions of at Least 30% From Baseline [ Time Frame: Baseline (last measurement collected prior to the first dose) to Week 12 ] [ Designated as safety issue: No ]
  • Hemoglobin: Mean Change From Baseline to Final Visit [ Time Frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) ] [ Designated as safety issue: Yes ]
  • Hematocrit: Mean Change From Baseline to Final Visit [ Time Frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) ] [ Designated as safety issue: Yes ]
  • Red Blood Cells: Mean Change From Baseline to Final Visit [ Time Frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) ] [ Designated as safety issue: Yes ]
  • White Blood Cells (WBC) and Platelet Count: Mean Change From Baseline to Final Visit [ Time Frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) ] [ Designated as safety issue: Yes ]
  • Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils: Mean Change From Baseline to Final Visit [ Time Frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) ] [ Designated as safety issue: Yes ]
  • Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactic Dehydrogenase (LDH), and Bone-Specific Alkaline Phosphatase (BSAP): Mean Change From Baseline to Final Visit [ Time Frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) ] [ Designated as safety issue: Yes ]
    n=subjects with evaluable Baseline and Post-baseline data for each parameter.

  • Bilirubin, Blood Urea Nitrogen (BUN), Uric Acid, Magnesium, Glucose, Cholesterol, Triglycerides, High Sensitivity C-Reactive Protein (hsCRP), Inorganic Phosphate, Corrected Calcium, and Creatinine: Mean Change From Baseline to Final Visit [ Time Frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) ] [ Designated as safety issue: Yes ]
    n=subjects with evaluable Baseline and Post-baseline data for each parameter.

  • Alkaline Phosphatase: Mean Change From Baseline to Final Visit [ Time Frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) ] [ Designated as safety issue: Yes ]
  • Sodium, Potassium, Chloride, Bicarbonate: Mean Change From Baseline to Final Visit [ Time Frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) ] [ Designated as safety issue: Yes ]
  • Total Protein and Albumin: Mean Change From Baseline to Final Visit [ Time Frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) ] [ Designated as safety issue: Yes ]
    n=subjects with evaluable Baseline and Post-baseline data for each parameter.

  • Fibroblast Growth Factor-23 (FGF-23), 1,25-Hydroxy Vitamin D, 25-Hydroxy Vitamin D, and Intact Parathyroid Hormone (iPTH): Mean Change From Baseline to Final Visit [ Time Frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) ] [ Designated as safety issue: Yes ]
    n=subjects with evaluable Baseline and Post-baseline data for each parameter.

  • Osteocalcin: Mean Change From Baseline to Final Visit [ Time Frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) ] [ Designated as safety issue: Yes ]
  • Number of Subjects With Adverse Events [ Time Frame: From first dose of study drug until 30 days following last dose of study drug (up to 16 weeks). ] [ Designated as safety issue: Yes ]
    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.

  • Number of Subjects With Potentially Clinically Significant Electrocardiogram (ECG) Findings [ Time Frame: Baseline (Day 1) to Final Visit (up to Week 12) ] [ Designated as safety issue: Yes ]
    12-lead ECGs were recorded after the subject had been in the supine position for at least 5 minutes. The number of subjects with potentially clinically significant ECG findings, as determined by the investigator, is presented.

  • Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Mean Change From Baseline to Final Visit [ Time Frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) ] [ Designated as safety issue: Yes ]
    Blood pressure was measured after the subject had been sitting for at least 3 minutes.

  • Heart Rate: Mean Change From Baseline to Final Visit [ Time Frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) ] [ Designated as safety issue: Yes ]
    Heart rate was measured after the subject had been sitting for at least 3 minutes.

  • Oral Body Temperature: Mean Change From Baseline to Final Visit [ Time Frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) ] [ Designated as safety issue: Yes ]
  • Number of Subjects With Potentially Clinically Significant Physical Examination Findings [ Time Frame: Baseline (Day 1) and Final Visit (up 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 paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Drug: paricalcitol
Paricalcitol soft capsule. Starting dose of paricalcitol was determined by the intact parathyroid hormone (iPTH) value (iPTH/120) from prior to Day 1, rounded down to the nearest whole number, not to exceed 16 µg 3 times weekly, no more frequently than every other day. Decisions to hold, maintain, increase, or decrease a dose were based on the iPTH, phosphorus, and calcium results generated from the most recent visit and within target Kidney Dialysis Outcomes Quality Initiatives (KDOQI) levels.
Other Name: ABT-358, Zemplar

  Eligibility

Ages Eligible for Study:   10 Years to 16 Years   (Child)
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
  • 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 must meet 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 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

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

Additional Information:
Responsible Party: 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
Results First Received: September 16, 2016
Last Updated: November 8, 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
Hyperparathyroidism, Secondary
Urologic Diseases
Renal Insufficiency
Parathyroid Diseases
Endocrine System Diseases
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on December 09, 2016