Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
43 participants
INTERVENTIONAL
2011-06-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
placebo
Placebo tablets and capsules for sprinkling identical to active treatment.
Standard of Care
All participants, regardless of treatment assignment, will receive standard of care with vitamin D sterols (calcitriol and its analogs), as prescribed by the treating physician.
Cinacalcet
Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks.
cinacalcet capsule
Cinacalcet was prepared for oral administration as both capsules for sprinkling and film coated tablets for swallowing.
Standard of Care
All participants, regardless of treatment assignment, will receive standard of care with vitamin D sterols (calcitriol and its analogs), as prescribed by the treating physician.
Interventions
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cinacalcet capsule
Cinacalcet was prepared for oral administration as both capsules for sprinkling and film coated tablets for swallowing.
placebo
Placebo tablets and capsules for sprinkling identical to active treatment.
Standard of Care
All participants, regardless of treatment assignment, will receive standard of care with vitamin D sterols (calcitriol and its analogs), as prescribed by the treating physician.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosed with CKD and SHPT receiving hemodialysis or peritoneal dialysis for ≥ 2 months before randomization
* Dry weight ≥ 12.5 kg at screening
* iPTH obtained from the central laboratory must be \> 300 pg/mL (31.8 pmol/L)
* Serum calcium (corrected) obtained from the central laboratory must be ≥ 8.8 mg/dL (2.2 mmol/L)
* Serum phosphorus obtained from the central laboratory ≥ 4.0 mg/dL (1.3 mmol/L) for children 6 to less than 12 years old, or ≥ 3.5 mg/dL (1.1 mmol/L) for children 12 to less than 18 years old
* Subjects already receiving vitamin D sterols (either calcitriol or a synthetic analog), a stable dose within the last 2 months prior to randomization
* Subjects taking growth hormone, a stable dose defined as no change \> than 20% in the last 2 months prior to randomization
* Subjects on anti-convulsant medication must be on a stable dose for 3 months, and have a therapeutic blood level of the anti-convulsant at the time of randomization
* Subjects must be on a dialysate calcium concentration of ≥ 2.5 mEq/L (1.25 mmol/L) for at least 2 months prior to randomization
Exclusion Criteria
* Anticipated parathyroidectomy within 6 months after randomization
* Received therapy with cinacalcet (sensipar/mimpara) within the last month
* A new onset of seizure or worsening of a pre-existing seizure disorder within the last 3 months
* Scheduled date for kidney transplant from a known living donor that makes completion of the study unlikely
6 Years
17 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Westmead, New South Wales, Australia
Research Site
Herston, Queensland, Australia
Research Site
Parkville, Victoria, Australia
Research Site
Brussels, , Belgium
Research Site
Edegem, , Belgium
Research Site
Ghent, , Belgium
Research Site
Leuven, , Belgium
Research Site
Heidelberg, , Germany
Research Site
Marburg, , Germany
Research Site
Budapest, , Hungary
Research Site
Debrecen, , Hungary
Research Site
Pécs, , Hungary
Research Site
Szeged, , Hungary
Research Site
Mexico City, Mexico City, Mexico
Research Site
Aguascalientes, , Mexico
Research Site
Gdansk, , Poland
Research Site
Gorzów Wielkopolski, , Poland
Research Site
Lodz, , Poland
Research Site
Warsaw, , Poland
Research Site
Warsaw, , Poland
Research Site
Moscow, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Samara, , Russia
Research Site
Banská Bystrica, , Slovakia
Research Site
Bratislava, , Slovakia
Research Site
Košice, , Slovakia
Research Site
Barakaldo, Basque Country, Spain
Research Site
Barcelona, Catalonia, Spain
Research Site
Barcelona, Cataluña, Spain
Research Site
Barakaldo, PaÃ-s Vasco, Spain
Research Site
Valencia, Valencia, Spain
Research Site
Madrid, , Spain
Research Site
Birmingham, Alabama, United States
Research Site
Los Angeles, California, United States
Research Site
San Francisco, California, United States
Research Site
Gainesville, Florida, United States
Research Site
Baltimore, Maryland, United States
Research Site
Boston, Massachusetts, United States
Research Site
Kansas City, Missouri, United States
Research Site
St Louis, Missouri, United States
Research Site
St Louis, Missouri, United States
Research Site
Livingston, New Jersey, United States
Research Site
The Bronx, New York, United States
Research Site
Greenville, North Carolina, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Portland, Oregon, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Houston, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Charlottesville, Virginia, United States
Research Site
Randwick, New South Wales, Australia
Countries
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References
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Warady BA, Iles JN, Ariceta G, Dehmel B, Hidalgo G, Jiang X, Laskin B, Shahinfar S, Vande Walle J, Schaefer F. A randomized, double-blind, placebo-controlled study to assess the efficacy and safety of cinacalcet in pediatric patients with chronic kidney disease and secondary hyperparathyroidism receiving dialysis. Pediatr Nephrol. 2019 Mar;34(3):475-486. doi: 10.1007/s00467-018-4116-y. Epub 2018 Nov 30.
Warady BA, Ng E, Bloss L, Mo M, Schaefer F, Bacchetta J. Cinacalcet studies in pediatric subjects with secondary hyperparathyroidism receiving dialysis. Pediatr Nephrol. 2020 Sep;35(9):1679-1697. doi: 10.1007/s00467-020-04516-4. Epub 2020 May 4.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20070208
Identifier Type: -
Identifier Source: org_study_id
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