Clinical trial NCT01382212: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: End-Stage Renal Disease
Secondary Hyperparathyroidism
Keywords: Evaluate safety through the evaluation of the incidence of hypercalcemia in pediatric subjects
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2011-06-27
Enrollment: 13
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of Subjects With Hypercalcemia
timeFrame: Day 1 to Week 12
Secondary outcomes:
measure: Percentage of Subjects With 2 Consecutive Intact Parathyroid Hormone (iPTH)/120 Between 150 and 300 pg/mL
timeFrame: Baseline (last measurement collected prior to the first dose) to Week 12
measure: Percentage of Subjects With 2 Consecutive iPTH Reductions of at Least 30% From Baseline
timeFrame: Baseline (last measurement collected prior to the first dose) to Week 12
measure: Hemoglobin: Mean Change From Baseline to Final Visit
timeFrame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
measure: Hematocrit: Mean Change From Baseline to Final Visit
timeFrame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
measure: Red Blood Cells: Mean Change From Baseline to Final Visit
timeFrame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
measure: White Blood Cells (WBC) and Platelet Count: Mean Change From Baseline to Final Visit
timeFrame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
measure: Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils: Mean Change From Baseline to Final Visit
timeFrame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
measure: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactic Dehydrogenase (LDH), and Bone-Specific Alkaline Phosphatase (BSAP): Mean Change From Baseline to Final Visit
timeFrame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
measure: 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
timeFrame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
measure: Alkaline Phosphatase: Mean Change From Baseline to Final Visit
timeFrame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
measure: Sodium, Potassium, Chloride, Bicarbonate: Mean Change From Baseline to Final Visit
timeFrame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
measure: Total Protein and Albumin: Mean Change From Baseline to Final Visit
timeFrame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
measure: 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
timeFrame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
measure: Osteocalcin: Mean Change From Baseline to Final Visit
timeFrame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
measure: Number of Subjects With Adverse Events
timeFrame: From first dose of study drug until 30 days following last dose of study drug (up to 16 weeks).
measure: Number of Subjects With Potentially Clinically Significant Electrocardiogram (ECG) Findings
timeFrame: Baseline (Day 1) to Final Visit (up to Week 12)
measure: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Mean Change From Baseline to Final Visit
timeFrame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
measure: Heart Rate: Mean Change From Baseline to Final Visit
timeFrame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
measure: Oral Body Temperature: Mean Change From Baseline to Final Visit
timeFrame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
measure: Number of Subjects With Potentially Clinically Significant Physical Examination Findings
timeFrame: Baseline (Day 1) and Final Visit (up to Week 12)
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: Ann Eldred, MD
role: STUDY_DIRECTOR
References:
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.