Phase 3 N=12 Randomized Double-blind Treatment

Safety and Efficacy of Paricalcitol Capsules in Decreasing Serum Parathyroid Hormone Levels in Children Aged 10-16 With Chronic Kidney Disease (CKD)

Chronic Kidney Disease Stage 3 and 4

Bottom Line

View on ClinicalTrials.gov: NCT01020487 ↗

Enrolled (actual)

Serious AEs

5.2%

Results posted

Mar 2017

Primary outcome: Primary: Part 1: Paricalcitol Maximum Observed Plasma Concentration (Cmax) — 0.13 ng/mL

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Paricalcitol (Drug); Placebo (Drug)
Age: Pediatric · 10+ yrs
Sex: All
Sponsor: AbbVie (prior sponsor, Abbott)
Primary completion: May 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Part 1: Paricalcitol Maximum Observed Plasma Concentration (Cmax)	0.13	—
PRIMARY Part 1: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-∞)	2.87	—
PRIMARY Part 2: Percentage of Participants Achieving Two Consecutive Reductions at Least 30% From Baseline in iPTH	0; 27.8	0.045 sig
SECONDARY Part 2: Percentage of Participants Achieving a Final iPTH Within KDOQI Target Ranges	11.1; 33.3	0.128
SECONDARY Part 2: Change From Baseline in iPTH to Each Post-baseline Visit	50.39; -12.16; 57.16; -11.27; 57.31; -12.79	< 0.001 sig
SECONDARY Part 2: Percentage of Participants Achieving Final Calcium Levels Within KDOQI Target Ranges	94.4; 83.3	0.327
SECONDARY Part 2: Percentage of Participants Achieving Final Phosphorus Levels Within KDOQI Target Ranges	72.2; 50.0	0.194
SECONDARY Part 2: Change From Baseline in First Morning Void (FMV) Urinary Albumin to Creatinine Ratio (UACR)	-0.12; -0.13; -0.13; -0.01; -0.08; 0.22	0.469

Summary

Part 1: To determine the safety, tolerability, and pharmacokinetics of a single dose of 3 μg paricalcitol capsules in children ages 10 to 16 years with moderate to severe chronic kidney disease (CKD Stages 3 and 4). Part 2: To determine the safety and efficacy of paricalcitol capsules as compared to placebo in decreasing serum intact parathyroid hormone (iPTH) in children ages 10 to 16 years with moderate to severe chronic kidney disease with an initial 12 weeks of double-blinded study drug followed by a minimum of 12 weeks of open-label active drug.

Eligibility Criteria

Inclusion Criteria

Subject has chronic kidney disease Stage 3 or 4 as determined by estimated glomerular filtration rate (15 to 59 mL/min/1.73 m²) at Screening.
Subject is not expected to begin dialysis for at least 6 months (in the opinion of the investigator).
For entry into the Washout Period (for subjects who are currently on a vitamin D receptor activator [VDRA] and need to complete a 2 to 4 week washout), the subject must satisfy the following criteria based on the Screening laboratory values:
estimated glomerular filtration rate between 15 to 59 mL/min/1.73 m².
iPTH measurement that is greater than or equal to 60 pg/mL (Stage 3 subjects) or greater than or equal to 90 pg/mL (Stage 4 subjects).
An adjusted serum calcium value greater than or equal to 8.2 mg/dL (2.05 mmol/L) to less than or equal to 10.5 mg/dL (2.63 mmol/L).
A serum phosphorus value greater than or equal to 2.0 mg/dL (0.65 mmol/L but less than or equal to 6.0 mg/dL (1.94 mmol/L).
For entry into the Treatment Phase (vitamin D receptor activator naïve subjects and those that have completed a 4 week washout), the subject must have:
iPTH measurement that is greater than or equal to 75 pg/mL (Stage 3 subjects) or greater than or equal to 110 pg/mL (Stage 4 subjects).
An adjusted serum calcium value greater than or equal to 8.4 mg/dL (2.10 mmol/L) but less than or equal to 10.2 mg/dL (2.55 mmol/L).
A serum phosphorus value greater than or equal to 2.5 mg/dL (0.81 mmol/L) but less than or equal to 5.8 mg/dL (1.87 mmol/L).
Must have 25-hydroxyvitamin D levels ≥ 30 ng/mL prior to washout, if not VDRA naïve, or treatment in Part II of the study.

Exclusion Criteria

All subjects that have had a small bowel transplant will be excluded from the study.
Subject has had acute kidney failure within 12 weeks of the Screening Phase (defined as an acute rise in serum creatinine).
Subject has had symptomatic or significant hypocalcemia requiring active vitamin D therapy (for example, calcitriol, paricalcitol, doxercalciferol or alfacalcidol) within 6 months prior to the Screening Phase.
Subject has a history of active kidney stones (6 months prior to screening).
Subject has chronic gastrointestinal disease, which in the investigator's opinion may cause significant gastrointestinal malabsorption.
Subject is taking maintenance calcitonin, bisphosphonates, cinacalcet, glucocorticoids in an equivalent dose of greater than 5 mg prednisone daily, or other drugs known to affect calcium or bone metabolism within 4 weeks prior to treatment.

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Data sourced from ClinicalTrials.gov (NCT01020487). 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.