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Clinical Trial Details

Trial ID: L1303
Source ID: NCT01382212
Associated Drug: Paricalcitol
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
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01382212/results
Conditions: End-Stage Renal Disease|Secondary Hyperparathyroidism
Interventions: DRUG: paricalcitol
Outcome Measures: Primary: 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)., Day 1 to Week 12 | Secondary: 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)|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)|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)|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., 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, n=subjects with evaluable Baseline and Post-baseline data for each parameter., Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|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)|Total Protein and Albumin: Mean Change From Baseline to Final Visit, n=subjects with evaluable Baseline and Post-baseline data for each parameter., 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, n=subjects with evaluable Baseline and Post-baseline data for each parameter., 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 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., From first dose of study drug until 30 days following last dose of study drug (up to 16 weeks).|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., 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, Blood pressure was measured after the subject had been sitting for at least 3 minutes., 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, Heart rate was measured after the subject had been sitting for at least 3 minutes., 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)|Number of Subjects With Potentially Clinically Significant Physical Examination Findings, Baseline (Day 1) and Final Visit (up to Week 12)
Sponsor/Collaborators: Sponsor: AbbVie (prior sponsor, Abbott)
Gender: ALL
Age: CHILD
Phases: PHASE3
Enrollment: 13
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2011-10
Completion Date: 2015-04
Results First Posted: 2016-11-21
Last Update Posted: 2018-07-02
Locations:
URL: https://clinicaltrials.gov/show/NCT01382212