Phase 3
N=13
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
End-Stage Renal Disease · Secondary Hyperparathyroidism
Bottom Line
View on ClinicalTrials.gov: NCT01382212 ↗Enrolled (actual)
13
Serious AEs
15.4%
Results posted
Nov 2016
Primary outcome: Primary: Percentage of Subjects With Hypercalcemia — 15.3 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- paricalcitol (Drug)
- Age
- Pediatric · 10+ yrs
- Sex
- All
- Sponsor
- AbbVie (prior sponsor, Abbott)
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Hypercalcemia |
15.3 | — |
| SECONDARY Percentage of Subjects With 2 Consecutive Intact Parathyroid Hormone (iPTH)/120 Between 150 and 300 pg/mL |
38.5 | — |
| SECONDARY Percentage of Subjects With 2 Consecutive iPTH Reductions of at Least 30% From Baseline |
61.5 | — |
| SECONDARY Hemoglobin: Mean Change From Baseline to Final Visit |
-0.1 | — |
| SECONDARY Hematocrit: Mean Change From Baseline to Final Visit |
-1.08 | — |
| SECONDARY Red Blood Cells: Mean Change From Baseline to Final Visit |
-0.09 | — |
| SECONDARY White Blood Cells (WBC) and Platelet Count: Mean Change From Baseline to Final Visit |
-0.06; 19.2 | — |
| SECONDARY Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils: Mean Change From Baseline to Final Visit |
0.11; -0.294; 0.032; 0.059; -0.01 | — |
| SECONDARY Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactic Dehydrogenase (LDH), and Bone-Specific Alkaline Phosphatase (BSAP): Mean Change From Baseline to Final Visit |
-4.55; -4.45; -6.5; -49.4 | — |
| SECONDARY 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 |
0.032; 0.013; 0.056; 1.33; 0.31; 0.082 | — |
| SECONDARY Alkaline Phosphatase: Mean Change From Baseline to Final Visit |
-61.8 | — |
| SECONDARY Sodium, Potassium, Chloride, Bicarbonate: Mean Change From Baseline to Final Visit |
-0.5; 0.25; 0.5; -0.45 | — |
| SECONDARY Total Protein and Albumin: Mean Change From Baseline to Final Visit |
0.15; 0.04 | — |
| SECONDARY 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 |
1990.7; 15.65; 5.8; -437.5 | — |
| SECONDARY Osteocalcin: Mean Change From Baseline to Final Visit |
117.21 | — |
| SECONDARY Number of Subjects With Adverse Events |
11; 2 | — |
| SECONDARY Number of Subjects With Potentially Clinically Significant Electrocardiogram (ECG) Findings |
— | — |
| SECONDARY Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Mean Change From Baseline to Final Visit |
7.5; 3.7 | — |
| SECONDARY Heart Rate: Mean Change From Baseline to Final Visit |
1.8 | — |
| SECONDARY Oral Body Temperature: Mean Change From Baseline to Final Visit |
0.03 | — |
| SECONDARY Number of Subjects With Potentially Clinically Significant Physical Examination Findings |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT01382212). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.