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

AbbVie (prior sponsor, Abbott)0 sites13 target enrollmentOctober 2011

ConditionsEnd-Stage Renal Disease Secondary Hyperparathyroidism

Interventionsparicalcitol

Drugsparicalcitol

Overview

Phase: Phase 3
Intervention: paricalcitol
Conditions: End-Stage Renal Disease
Sponsor: AbbVie (prior sponsor, Abbott)
Enrollment: 13
Primary Endpoint: Percentage of Subjects With Hypercalcemia
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2011

End Date

April 2015

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

AbbVie (prior sponsor, Abbott)

Responsible Party

Sponsor

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

Arms & Interventions

Paricalcitol

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

Intervention: paricalcitol

Outcomes

Primary Outcomes

Percentage of Subjects With Hypercalcemia

Time Frame: Day 1 to Week 12

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 Outcomes

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