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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01020487
First received: November 13, 2009
Last updated: June 20, 2014
Last verified: June 2014

November 13, 2009
June 20, 2014
February 2010
May 2014   (final data collection date for primary outcome measure)
The primary efficacy-endpoint is the proportion of subjects who achieve two consecutive greater than or equal to 30 percent reductions from baseline in intact parathyroid hormone levels. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
The primary efficacy measure for intact parathyroid hormone in pediatric Chronic Kidney Disease subjects is determined by the stage of Chronic Kidney Disease. The data is collected via blood draws.
The proportion of subjects who achieve at least two consecutive iIntact Parathyroid hormone (iPTH) values within the applicable Kidney Dialysis Outcomes Quality Initiatives (K/DOQI) iPTH target ranges [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01020487 on ClinicalTrials.gov Archive Site
  • The proportion of subjects who achieve a final intact parathyroid hormone values within Kidney Disease Outcomes Quality Initiative intact parathyroid hormone target ranges will be evaluated within each Chronic Kidney Disease stage. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • The proportion of subjects who achieve a final value within the applicable Kidney Disease Outcomes Quality Initiative target ranges for calcium. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • The proportion of subjects who achieve a final value within the applicable Kidney Disease Outcomes Quality Initiative target ranges for phosphorus. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • The mean percent change in intact parathyroid hormone from baseline to each post baseline visit (Weeks 2, 4, 8 and 12). [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
  • The mean percent change in intact parathyroid hormone from baseline to each post baseline visit (Weeks 2, 4, 8 and 12). [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
  • The mean percent change in intact parathyroid hormone from baseline to each post baseline visit (Weeks 2, 4, 8 and 12). [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
  • The mean percent change in intact parathyroid hormone from baseline to each post baseline visit (Weeks 2, 4, 8 and 12). [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • The mean change in First Morning Void Urine Albumin/Creatinine Ratio from baseline to each post baseline visit (Weeks 4, 8 and 12). [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
  • The mean change in First Morning Void Urine Albumin/Creatinine Ratio from baseline to each post baseline visit (Weeks 4, 8 and 12). [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
  • The mean change in First Morning Void Urine Albumin/Creatinine Ratio from baseline to each post baseline visit (Weeks 4, 8 and 12). [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • The proportion of subjects who achieve 2 consecutive >= 30% reductions in iPTH compared to baseline [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • The mean percent change in iPTH over each visit [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • The proportion of subjects who achieve 2 consecutive values within the K/DOQI target ranges for calcium and for phosphorus [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Efficacy of Paricalcitol Capsules in Decreasing Serum Parathyroid Hormone Levels in Children 10-16 With Chronic Kidney Disease (CKD)
Phase 3, Prospective, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Paricalcitol Capsules in Decreasing Serum Intact Parathyroid Hormone Levels in Pediatric Subjects Ages 10 to 16 Years With Moderate to Severe Chronic Kidney Disease

Safety and efficacy study using Paricalcitol capsules to decrease parathyroid hormone levels in children ages 10 to 16 with Chronic Kidney Disease.

The study consists of two parts. Part I is an open-label single-dose, non-fasting, multicenter study to evaluate the pharmacokinetics of paricalcitol capsules in 12 pediatric subjects ages 10 to 16 years with Chronic Kidney Disease Stages 3 and 4. Part II of this study will be conducted as a 12 week randomized double-blind, placebo-controlled study, followed by 12 weeks open-label treatment. Subjects active or enrolled under amendment 5 will enter a Follow-Up period and have study visits every 4 weeks until the final subject reaches Week 24. The objective of this multicenter study is to evaluate the safety and efficacy of paricalcitol capsules in decreasing serum intact parathyroid hormone levels to the National Kidney Foundation's Kidney Disease Outcomes Quality Initiative target goals in 36 pediatric subjects ages 10 to 16 years with Chronic Kidney Disease Stages 3 and 4.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Chronic Kidney Disease Stage 3 and 4
  • Drug: Zemplar (paricalcitol) Capsules
    Group 1 - Paricalcitol capsules 1 - 3 mcg TIW (one to three Paricalcitol 1 mcg capsules TIW).
  • Drug: Placebo capsules
    Group 2 - Placebo TIW (one to three placebo capsules TIW)
  • Experimental: Paricalcitol capsules (1 - 3 mcg dose)
    Intervention: Drug: Zemplar (paricalcitol) Capsules
  • Placebo Comparator: Placebo (1 -3 capsules per dose)
    Intervention: Drug: Placebo capsules
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
48
March 2015
May 2014   (final data collection date for primary outcome measure)

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 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 (estimate by the Schwartz formula as outlined in Section 5.3.1.2).
    • 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.
Both
10 Years to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany,   Portugal,   Puerto Rico,   Singapore,   Spain,   United Kingdom
 
NCT01020487
M10-149, 2010-019439-37
No
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Ann Eldred, MD AbbVie
AbbVie
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP