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Clinical Trial Details

Trial ID: L1180
Source ID: NCT01020487
Associated Drug: Paricalcitol
Title: Safety and Efficacy of Paricalcitol Capsules in Decreasing Serum Parathyroid Hormone Levels in Children Aged 10-16 With Chronic Kidney Disease (CKD)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01020487/results
Conditions: Chronic Kidney Disease Stage 3 and 4
Interventions: DRUG: Paricalcitol|DRUG: Placebo
Outcome Measures: Primary: Part 1: Paricalcitol Maximum Observed Plasma Concentration (Cmax), Blood samples were collected at hour 0, 1, 2, 4, 6, 8, 12, 24, 36, and 48 hours after dosing.|Part 1: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-∞), Blood samples were collected at hour 0, 1, 2, 4, 6, 8, 12, 24, 36, and 48 hours after dosing.|Part 2: Percentage of Participants Achieving Two Consecutive Reductions at Least 30% From Baseline in iPTH, The primary efficacy endpoint was the percentage of participants who achieved two consecutive ≥ 30% reductions from baseline in intact parathyroid hormone (iPTH) levels during the 12 week double-blind portion of the study regardless of CKD stage., 12-week double-blind treatment period | Secondary: Part 2: Percentage of Participants Achieving a Final iPTH Within KDOQI Target Ranges, The Kidney Disease Outcomes Quality Initiatives (KDOQI) Pediatric Subcommittee on Practice Guidelines for Bone Metabolism and Disease in Children with CKD target range for intact parathyroid hormone (iPTH) is as follows:: CKD Stage 3: 35 - 69 pg/mL; CKD Stage 4: 70 - 110 pg/mL., Week 12|Part 2: Change From Baseline in iPTH to Each Post-baseline Visit, Baseline and Weeks 2, 4, 8 and 12|Part 2: Percentage of Participants Achieving Final Calcium Levels Within KDOQI Target Ranges, KDOQI recommends serum calcium is maintained within age appropriate normal ranges: Age 6 - 12: 9.4 - 10.2 mg/dL (2.35 - 2.55 mmol/L); Age 13 - 20: 8.8 - 10.2 mg/dL (2.20 - 2.55 mmol/L)., Week 12|Part 2: Percentage of Participants Achieving Final Phosphorus Levels Within KDOQI Target Ranges, The KDOQI target ranges of serum phosphorus are to maintain at or above age appropriate lower limits and no higher than the age-appropriate upper limits: Age 6 - 12: 3.6 - 5.8 mg/dL (1.16 - 1.87 mmol/L); Age 13 - 20: 2.3 - 4.5 mg/dL (0.74 - 1.45 mmol/L)., Week 12|Part 2: Change From Baseline in First Morning Void (FMV) Urinary Albumin to Creatinine Ratio (UACR), The mean change from Baseline in FMV UACR on a log scale to each post baseline visit., Baseline and Weeks 4, 8 and 12
Sponsor/Collaborators: Sponsor: AbbVie (prior sponsor, Abbott)
Gender: ALL
Age: CHILD
Phases: PHASE3
Enrollment: 47
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2010-02
Completion Date: 2014-12
Results First Posted: 2017-03-29
Last Update Posted: 2018-07-02
Locations:
URL: https://clinicaltrials.gov/show/NCT01020487