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: August 18, 2014
Last verified: August 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: December 2014
Primary Completion Date: May 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01020487

  Hide Study Locations
Locations
United States, California
Site Reference ID/Investigator# 22256
Los Angeles, California, United States, 90027
Site Reference ID/Investigator# 22262
Los Angeles, California, United States, 90095-1752
United States, Florida
Site Reference ID/Investigator# 24343
Miami, Florida, United States, 33136
United States, Georgia
Site Reference ID/Investigator# 22250
Atlanta, Georgia, United States, 30322
United States, Iowa
Site Reference ID/Investigator# 23107
Iowa City, Iowa, United States, 52242
United States, Kentucky
Site Reference ID/Investigator# 23743
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Site Reference ID/Investigator# 24844
Boston, Massachusetts, United States, 02114
United States, Missouri
Site Reference ID/Investigator# 22268
Kansas City, Missouri, United States, 64108
United States, Ohio
Site Reference ID/Investigator# 22246
Cleveland, Ohio, United States, 44106
Site Reference ID/Investigator# 22257
Columbus, Ohio, United States, 43205
United States, Oklahoma
Site Reference ID/Investigator# 37134
Oklahoma City, Oklahoma, United States, 73104
United States, Texas
Site Reference ID/Investigator# 22249
Houston, Texas, United States, 77030
United States, Utah
Site Reference ID/Investigator# 22263
Salt Lake City, Utah, United States, 84113
United States, Wisconsin
Site Reference ID/Investigator# 23122
Milwaukee, Wisconsin, United States, 53226
Germany
Site Reference ID/Investigator# 38562
Berlin, Germany, 13353
Site Reference ID/Investigator# 38363
Cologne, Germany, 50937
Site Reference ID/Investigator# 39968
Hamburg, Germany, 20251
Site Reference ID/Investigator# 38563
Hannover, Germany, 30625
Site Reference ID/Investigator# 38964
Marburg, Germany, 35043
Site Reference ID/Investigator# 38362
Munich, Germany, 80337
Portugal
Site Reference ID/Investigator# 38967
Coimbra, Portugal, 3000-602
Site Reference ID/Investigator# 38966
Porto, Portugal, 4200-319
Site Reference ID/Investigator# 38968
Porto, Portugal, 4099-001
Puerto Rico
Site Reference ID/Investigator# 26602
San Juan, Puerto Rico, 00935
Singapore
Site Reference ID/Investigator# 40070
Singapore, Singapore, 229899
Site Reference ID/Investigator# 40071
Singapore, Singapore, 119074
Spain
Site Reference ID/Investigator# 39164
Barakaldo (Vizcaya), Spain, 48903
Site Reference ID/Investigator# 38963
Barcelona, Spain, 08035
Site Reference ID/Investigator# 41483
Barcelona, Spain, 08041
Site Reference ID/Investigator# 70513
Cordoba, Spain, 14004
Site Reference ID/Investigator# 38762
Madrid, Spain, 28046
Site Reference ID/Investigator# 69522
Santiago de Compostela, Spain, 15706
United Kingdom
Site Reference ID/Investigator# 38564
Birmingham, United Kingdom, B4 6NH
Site Reference ID/Investigator# 47163
Leeds, United Kingdom, LS1 3EX
Site Reference ID/Investigator# 38582
London, United Kingdom, WC1N 3JH
Site Reference ID/Investigator# 40702
London, United Kingdom, SE1 7EH
Site Reference ID/Investigator# 38282
Manchester, United Kingdom, M13 9WL
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: August 18, 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
Urologic Diseases
Renal Insufficiency
Hormones
Ergocalciferols
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Vitamins
Micronutrients
Growth Substances
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 16, 2014