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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

Primary Purpose

End-Stage Renal Disease, Secondary Hyperparathyroidism

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
paricalcitol
Sponsored by
AbbVie (prior sponsor, Abbott)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End-Stage Renal Disease focused on measuring Evaluate safety through the evaluation of the incidence of hypercalcemia in pediatric subjects

Eligibility Criteria

10 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Paricalcitol

    Arm Description

    Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.

    Outcomes

    Primary Outcome Measures

    Percentage of Subjects With Hypercalcemia
    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
    Percentage of Subjects With 2 Consecutive iPTH Reductions of at Least 30% From Baseline
    Hemoglobin: Mean Change From Baseline to Final Visit
    Hematocrit: Mean Change From Baseline to Final Visit
    Red Blood Cells: Mean Change From Baseline to Final Visit
    White Blood Cells (WBC) and Platelet Count: Mean Change From Baseline to Final Visit
    Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils: Mean Change From Baseline to Final Visit
    Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactic Dehydrogenase (LDH), and Bone-Specific Alkaline Phosphatase (BSAP): Mean Change From Baseline to Final Visit
    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
    n=subjects with evaluable Baseline and Post-baseline data for each parameter.
    Alkaline Phosphatase: Mean Change From Baseline to Final Visit
    Sodium, Potassium, Chloride, Bicarbonate: Mean Change From Baseline to Final Visit
    Total Protein and Albumin: Mean Change From Baseline to Final Visit
    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
    n=subjects with evaluable Baseline and Post-baseline data for each parameter.
    Osteocalcin: Mean Change From Baseline to Final Visit
    Number of Subjects With Adverse Events
    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
    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
    Blood pressure was measured after the subject had been sitting for at least 3 minutes.
    Heart Rate: Mean Change From Baseline to Final Visit
    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
    Number of Subjects With Potentially Clinically Significant Physical Examination Findings

    Full Information

    First Posted
    June 24, 2011
    Last Updated
    June 1, 2018
    Sponsor
    AbbVie (prior sponsor, Abbott)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01382212
    Brief Title
    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
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2011 (undefined)
    Primary Completion Date
    April 2015 (Actual)
    Study Completion Date
    April 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    AbbVie (prior sponsor, Abbott)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    End-Stage Renal Disease, Secondary Hyperparathyroidism
    Keywords
    Evaluate safety through the evaluation of the incidence of hypercalcemia in pediatric subjects

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    13 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Paricalcitol
    Arm Type
    Experimental
    Arm Description
    Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    paricalcitol
    Other Intervention Name(s)
    ABT-358, Zemplar
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Percentage of Subjects With Hypercalcemia
    Description
    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).
    Time Frame
    Day 1 to Week 12
    Secondary Outcome Measure Information:
    Title
    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
    Title
    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
    Title
    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)
    Title
    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)
    Title
    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)
    Title
    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)
    Title
    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)
    Title
    Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactic Dehydrogenase (LDH), and Bone-Specific Alkaline Phosphatase (BSAP): Mean Change From Baseline to Final Visit
    Description
    n=subjects with evaluable Baseline and Post-baseline data for each parameter.
    Time Frame
    Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
    Title
    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
    Description
    n=subjects with evaluable Baseline and Post-baseline data for each parameter.
    Time Frame
    Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
    Title
    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)
    Title
    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)
    Title
    Total Protein and Albumin: Mean Change From Baseline to Final Visit
    Description
    n=subjects with evaluable Baseline and Post-baseline data for each parameter.
    Time Frame
    Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
    Title
    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
    Description
    n=subjects with evaluable Baseline and Post-baseline data for each parameter.
    Time Frame
    Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
    Title
    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)
    Title
    Number of Subjects With Adverse Events
    Description
    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.
    Time Frame
    From first dose of study drug until 30 days following last dose of study drug (up to 16 weeks).
    Title
    Number of Subjects With Potentially Clinically Significant Electrocardiogram (ECG) Findings
    Description
    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.
    Time Frame
    Baseline (Day 1) to Final Visit (up to Week 12)
    Title
    Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Mean Change From Baseline to Final Visit
    Description
    Blood pressure was measured after the subject had been sitting for at least 3 minutes.
    Time Frame
    Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
    Title
    Heart Rate: Mean Change From Baseline to Final Visit
    Description
    Heart rate was measured after the subject had been sitting for at least 3 minutes.
    Time Frame
    Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
    Title
    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)
    Title
    Number of Subjects With Potentially Clinically Significant Physical Examination Findings
    Time Frame
    Baseline (Day 1) and Final Visit (up to Week 12)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ann Eldred, MD
    Organizational Affiliation
    AbbVie
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28332096
    Citation
    Webb NJA, Lerner G, Warady BA, Dell KM, Greenbaum LA, Ariceta G, Hoppe B, Linde P, Lee HJ, Eldred A, Dufek MB. Efficacy and safety of paricalcitol in children with stages 3 to 5 chronic kidney disease. Pediatr Nephrol. 2017 Jul;32(7):1221-1232. doi: 10.1007/s00467-017-3579-6. Epub 2017 Mar 22.
    Results Reference
    result
    Links:
    URL
    http://www.rxabbvie.com
    Description
    Prescribing Information

    Learn more about this trial

    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

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