Efficacy and Safety of Cinacalcet in Pediatric Patients With Secondary Hyperparathyroidism (SHPT) and Chronic Kidney Disease (CKD) on Dialysis
NCT ID: NCT02138838
Last Updated: 2020-06-29
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
55 participants
INTERVENTIONAL
2014-11-07
2016-06-23
Brief Summary
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Detailed Description
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Participants in both treatment groups who completed the 20-week treatment period and those who ended the study due to study closure were eligible to enroll in an open-label extension study (20140159; NCT02341417) for further safety follow-up.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard of Care
Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.
Standard of Care
Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.
Cinacalcet
In addition to standard of care participants received cinacalcet at a starting dose (based on dry body weight) of 0.20 mg/kg administered once a day by mouth. Dose adjustments and withholding were based on ionized calcium levels, plasma iPTH, and corrected calcium levels.
Cinacalcet HCl
Capsules were opened and either sprinkled onto soft food (≥ 5 mg dose) or suspended into a sucrose syrup (≥ 2.5 mg dose) to create a liquid suspension for administration. Tablets were used for doses of 30 mg and higher in participants who could swallow tablets.
Standard of Care
Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.
Interventions
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Cinacalcet HCl
Capsules were opened and either sprinkled onto soft food (≥ 5 mg dose) or suspended into a sucrose syrup (≥ 2.5 mg dose) to create a liquid suspension for administration. Tablets were used for doses of 30 mg and higher in participants who could swallow tablets.
Standard of Care
Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of SHPT with the mean of the two consecutive central laboratory iPTH values ≥ 300 pg/mL during screening
* Corrected calcium value of ≥ 8.8 mg/dL during screening
* Diagnosis of CKD, receiving either hemodialysis or peritoneal dialysis, for ≥ 30 days prior to screening
* Parent or legally acceptable representative has provided written informed consent and subject has provided written assent when required by institutional guidelines
Exclusion Criteria
* Corrected QT interval (QTc) \> 500 ms, using Bazett's formula
* QTc ≥ 450 to ≤ 500 ms, using Bazett's formula, unless written permission to enroll is provided by the investigator after consultation with a pediatric cardiologist
* Use of grapefruit juice, herbal medications, or potent cytochrome P450 3A4 (CYP3A4) inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole)
* Use of concomitant medications that may prolong the QTc interval (eg, ondansetron, albuterol)
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
Los Angeles, California, United States
Research Site
Wilmington, Delaware, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Iowa City, Iowa, United States
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Louisville, Kentucky, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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Minneapolis, Minnesota, United States
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Jackson, Mississippi, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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St Louis, Missouri, United States
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West Orange, New Jersey, United States
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New York, New York, United States
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The Bronx, New York, United States
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Greenville, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Philadelphia, Pennsylvania, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Brussels, , Belgium
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Ghent, , Belgium
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Leuven, , Belgium
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Prague, , Czechia
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Bron, , France
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Lille, , France
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Marseille, , France
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Nice, , France
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Paris, , France
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Paris, , France
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Paris, , France
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Hanover, , Germany
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Heidelberg, , Germany
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Marburg, , Germany
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Athens, , Greece
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Thessaloniki, , Greece
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Budapest, , Hungary
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Szeged, , Hungary
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Genova, , Italy
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Napoli, , Italy
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Torino, , Italy
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Vilinus, , Lithuania
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Grafton, Auckland, , New Zealand
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Krakow, , Poland
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Lodz, , Poland
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Warsaw, , Poland
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Porto, , Portugal
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Moscow, , Russia
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Saint Petersburg, , Russia
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Samara, , Russia
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Košice, , Slovakia
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Barcelona, Catalonia, Spain
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Espluques de LLobregat, Catalonia, Spain
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Kyiv, , Ukraine
Countries
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References
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Chen P, Sohn W, Narayanan A, Gisleskog PO, Melhem M. Bridging adults and paediatrics with secondary hyperparathyroidism receiving haemodialysis: a pharmacokinetic-pharmacodynamic analysis of cinacalcet. Br J Clin Pharmacol. 2019 Jun;85(6):1312-1325. doi: 10.1111/bcp.13900. Epub 2019 Apr 25.
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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2013-004958-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20130356
Identifier Type: -
Identifier Source: org_study_id
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