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

This study is currently recruiting participants.
Verified January 2014 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01020487
First received: November 13, 2009
Last updated: January 5, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Chronic Kidney Disease Stage 3 and 4
Drug: Zemplar (paricalcitol) Capsules
Drug: Placebo capsules
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 48
Study Start Date: February 2010
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paricalcitol capsules (1 - 3 mcg dose) Drug: Zemplar (paricalcitol) Capsules
Group 1 - Paricalcitol capsules 1 - 3 mcg TIW (one to three Paricalcitol 1 mcg capsules TIW).
Placebo Comparator: Placebo (1 -3 capsules per dose) Drug: Placebo capsules
Group 2 - Placebo TIW (one to three placebo capsules TIW)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   10 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01020487

Contacts
Contact: Kim Grabbe, MS 847-935-7838 Kim.Grabbe@abbvie.com
Contact: Emily Kunka, BS 847-937-7312 emily.kunka@abbvie.com

  Hide Study Locations
Locations
United States, Arizona
Site Reference ID/Investigator# 27224 Withdrawn
Phoenix, Arizona, United States, 85016
United States, Arkansas
Site Reference ID/Investigator# 36269 Withdrawn
Little Rock, Arkansas, United States, 72202
United States, California
Site Reference ID/Investigator# 22256 Recruiting
Los Angeles, California, United States, 90027
Principal Investigator: Site Reference ID/Investigator# 22256         
Site Reference ID/Investigator# 22262 Recruiting
Los Angeles, California, United States, 90095-1752
Principal Investigator: Site Reference ID/Investigator# 22262         
United States, Florida
Site Reference ID/Investigator# 22259 Withdrawn
Miami, Florida, United States, 33155-4078
Site Reference ID/Investigator# 24343 Recruiting
Miami, Florida, United States, 33136
Principal Investigator: Site Reference ID/Investigator# 24343         
Site Reference ID/Investigator# 27608 Withdrawn
Orlando, Florida, United States, 32806
United States, Georgia
Site Reference ID/Investigator# 22250 Recruiting
Atlanta, Georgia, United States, 30322
Principal Investigator: Site Reference ID/Investigator# 22250         
United States, Illinois
Site Reference ID/Investigator# 22255 Withdrawn
Chicago, Illinois, United States, 60611
United States, Iowa
Site Reference ID/Investigator# 23107 Recruiting
Iowa City, Iowa, United States, 52242
Principal Investigator: Site Reference ID/Investigator# 23107         
United States, Kentucky
Site Reference ID/Investigator# 23743 Recruiting
Louisville, Kentucky, United States, 40202
Principal Investigator: Site Reference ID/Investigator# 23743         
United States, Massachusetts
Site Reference ID/Investigator# 24844 Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Site Reference ID/Investigator# 24844         
United States, Missouri
Site Reference ID/Investigator# 22268 Recruiting
Kansas City, Missouri, United States, 64108
Principal Investigator: Site Reference ID/Investigator# 22268         
United States, New York
Site Reference ID/Investigator# 22264 Withdrawn
Buffalo, New York, United States, 14222
United States, Ohio
Site Reference ID/Investigator# 22245 Withdrawn
Akron, Ohio, United States, 44308
Site Reference ID/Investigator# 22248 Withdrawn
Cincinnati, Ohio, United States, 45229
Site Reference ID/Investigator# 22246 Recruiting
Cleveland, Ohio, United States, 44106
Principal Investigator: Site Reference ID/Investigator# 22246         
Site Reference ID/Investigator# 22257 Recruiting
Columbus, Ohio, United States, 43205
Principal Investigator: Site Reference ID/Investigator# 22257         
United States, Oklahoma
Site Reference ID/Investigator# 37134 Recruiting
Oklahoma City, Oklahoma, United States, 73104
Principal Investigator: Site Reference ID/Investigator# 37134         
United States, Texas
Site Reference ID/Investigator# 22249 Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Site Reference ID/Investigator# 22249         
Site Reference ID/Investigator# 22266 Withdrawn
Houston, Texas, United States, 77030
United States, Utah
Site Reference ID/Investigator# 22263 Recruiting
Salt Lake City, Utah, United States, 84113
Principal Investigator: Site Reference ID/Investigator# 22263         
United States, Wisconsin
Site Reference ID/Investigator# 23242 Withdrawn
Madison, Wisconsin, United States, 53792
Site Reference ID/Investigator# 23122 Recruiting
Milwaukee, Wisconsin, United States, 53226
Principal Investigator: Site Reference ID/Investigator# 23122         
Germany
Site Reference ID/Investigator# 38562 Recruiting
Berlin, Germany, 13353
Principal Investigator: Site Reference ID/Investigator# 38562         
Site Reference ID/Investigator# 38363 Recruiting
Cologne, Germany, 50937
Principal Investigator: Site Reference ID/Investigator# 38363         
Site Reference ID/Investigator# 39968 Recruiting
Hamburg, Germany, 20251
Principal Investigator: Site Reference ID/Investigator# 39968         
Site Reference ID/Investigator# 38563 Recruiting
Hannover, Germany, 30625
Principal Investigator: Site Reference ID/Investigator# 38563         
Site Reference ID/Investigator# 38964 Recruiting
Marburg, Germany, 35043
Principal Investigator: Site Reference ID/Investigator# 38964         
Site Reference ID/Investigator# 38362 Recruiting
Munich, Germany, 80337
Principal Investigator: Site Reference ID/Investigator# 38362         
Portugal
Site Reference ID/Investigator# 38967 Recruiting
Coimbra, Portugal, 3000-602
Principal Investigator: Site Reference ID/Investigator# 38967         
Site Reference ID/Investigator# 38966 Recruiting
Porto, Portugal, 4200-319
Principal Investigator: Site Reference ID/Investigator# 38966         
Site Reference ID/Investigator# 38968 Recruiting
Porto, Portugal, 4099-001
Principal Investigator: Site Reference ID/Investigator# 38968         
Puerto Rico
Site Reference ID/Investigator# 26602 Recruiting
San Juan, Puerto Rico, 00935
Principal Investigator: Site Reference ID/Investigator# 26602         
Singapore
Site Reference ID/Investigator# 40070 Recruiting
Singapore, Singapore, 229899
Principal Investigator: Site Reference ID/Investigator# 40070         
Site Reference ID/Investigator# 40071 Recruiting
Singapore, Singapore, 119074
Principal Investigator: Site Reference ID/Investigator# 40071         
Spain
Site Reference ID/Investigator# 39164 Recruiting
Barakaldo (Vizcaya), Spain, 48903
Principal Investigator: Site Reference ID/Investigator# 39164         
Site Reference ID/Investigator# 41483 Recruiting
Barcelona, Spain, 08041
Principal Investigator: Site Reference ID/Investigator# 41483         
Site Reference ID/Investigator# 38963 Recruiting
Barcelona, Spain, 08035
Principal Investigator: Site Reference ID/Investigator# 38963         
Site Reference ID/Investigator# 70513 Recruiting
Cordoba, Spain, 14004
Principal Investigator: Site Reference ID/Investigator# 70513         
Site Reference ID/Investigator# 39967 Withdrawn
Esplugues Llobregat Barcelona, Spain, 08950
Site Reference ID/Investigator# 38762 Recruiting
Madrid, Spain, 28046
Principal Investigator: Site Reference ID/Investigator# 38762         
Site Reference ID/Investigator# 69522 Recruiting
Santiago de Compostela, Spain, 15706
Principal Investigator: Site Reference ID/Investigator# 69522         
Site Reference ID/Investigator# 38962 Withdrawn
Valencia, Spain, 46026
United Kingdom
Site Reference ID/Investigator# 38564 Recruiting
Birmingham, United Kingdom, B4 6NH
Principal Investigator: Site Reference ID/Investigator# 38564         
Site Reference ID/Investigator# 47163 Recruiting
Leeds, United Kingdom, LS1 3EX
Principal Investigator: Site Reference ID/Investigator# 47163         
Site Reference ID/Investigator# 38582 Recruiting
London, United Kingdom, WC1N 3JH
Principal Investigator: Site Reference ID/Investigator# 38582         
Site Reference ID/Investigator# 40702 Recruiting
London, United Kingdom, SE1 7EH
Principal Investigator: Site Reference ID/Investigator# 40702         
Site Reference ID/Investigator# 38282 Recruiting
Manchester, United Kingdom, M13 9WL
Principal Investigator: Site Reference ID/Investigator# 38282         
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Ann Eldred, MD AbbVie
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01020487     History of Changes
Other Study ID Numbers: M10-149, 2010-019439-37
Study First Received: November 13, 2009
Last Updated: January 5, 2014
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Spain: Spanish Agency of Medicines
Singapore: Health Sciences Authority
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Portugal: National Pharmacy and Medicines Institute

Keywords provided by AbbVie:
Reduction of parathyroid hormone levels in pediatric patients with Chronic Kidney Disease Stage 3 and 4

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency
Hormones
Ergocalciferols
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 17, 2014