- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02138838
Efficacy and Safety of Cinacalcet in Pediatric Patients With Secondary Hyperparathyroidism (SHPT) and Chronic Kidney Disease (CKD) on Dialysis
A Randomized, Open-label, Controlled Study to Assess the Efficacy and Safety of Cinacalcet HCl in Pediatric Subjects With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Dialysis
Study Overview
Status
Intervention / Treatment
Detailed Description
This was a 24-week, randomized, multicenter, open-label, controlled study. Participants were randomized into one of two treatment arms; oral administration of cinacalcet daily in addition to standard of care treatment, or standard of care alone. Randomization was stratified by age group (6 to < 12 and 12 to < 18 years of age). All participants received standard of care which could include therapy with Vitamin D sterols, calcium supplementation, and phosphate binders.
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Bruxelles, Belgium, 1020
- Research Site
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Gent, Belgium, 9000
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Leuven, Belgium, 3000
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Praha 5, Czechia, 150 06
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Bron cedex, France, 69677
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Lille, France, 59800
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Marseille cedex 05, France, 13385
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Nice cedex 3, France, 06202
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Paris, France, 75012
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Paris, France, 75015
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Paris, France, 75019
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Hannover, Germany, 30625
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Heidelberg, Germany, 69120
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Marburg, Germany, 35043
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Athens, Greece, 11527
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Thessaloniki, Greece, 54642
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Budapest, Hungary, 1083
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Szeged, Hungary, 6720
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Genova, Italy, 16147
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Napoli, Italy, 80129
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Torino, Italy, 10126
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Vilinus, Lithuania, 08406
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Grafton, Auckland, New Zealand, 1023
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Krakow, Poland, 30-663
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Lodz, Poland, 93-338
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Warszawa, Poland, 00-576
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Porto, Portugal, 4050 371
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Moscow, Russian Federation, 107014
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Saint Petersburg, Russian Federation, 198205
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Samara, Russian Federation, 443095
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Kosice, Slovakia, 040 11
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Cataluña
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Barcelona, Cataluña, Spain, 08035
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Espluques De LLobregat, Cataluña, Spain, 08950
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Kyiv, Ukraine, 01135
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California
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Los Angeles, California, United States, 90027
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Delaware
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Wilmington, Delaware, United States, 19803
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Georgia
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Atlanta, Georgia, United States, 30322
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Illinois
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Chicago, Illinois, United States, 60612
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Iowa
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Iowa City, Iowa, United States, 52242
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Kentucky
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Louisville, Kentucky, United States, 40202
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Maryland
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Baltimore, Maryland, United States, 21287
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Massachusetts
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Boston, Massachusetts, United States, 02115
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Michigan
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Detroit, Michigan, United States, 48201
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Minnesota
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Minneapolis, Minnesota, United States, 55454
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Mississippi
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Jackson, Mississippi, United States, 39216
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Missouri
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Kansas City, Missouri, United States, 64108
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Saint Louis, Missouri, United States, 63110
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Saint Louis, Missouri, United States, 63104
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New Jersey
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West Orange, New Jersey, United States, 07052
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New York
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Bronx, New York, United States, 10467
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New York, New York, United States, 10029
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North Carolina
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Greenville, North Carolina, United States, 27834
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Ohio
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Cincinnati, Ohio, United States, 45229
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Cleveland, Ohio, United States, 44106
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Columbus, Ohio, United States, 43205
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
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Texas
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Dallas, Texas, United States, 75235
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Houston, Texas, United States, 77030
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San Antonio, Texas, United States, 78229
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Utah
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Salt Lake City, Utah, United States, 84113
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 6 - < 18 years
- 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:
- History of congenital long QT syndrome, second or third degree heart block, ventricular tachyarrhythmias or other conditions associated with prolonged QT interval
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Standard of Care
Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.
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Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.
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Experimental: 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.
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Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Participants Who Achieved a ≥ 30% Reduction From Baseline In Mean Plasma iPTH During Weeks 11 to 15
Time Frame: Baseline and weeks 11 to 15
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Intact parathyroid hormone (iPTH) levels were measured at weeks 11 and 15; the mean value from these 2 measurements was calculated. This endpoint was the primary endpoint in the US only. |
Baseline and weeks 11 to 15
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Percentage of Participants Who Achieved a ≥ 30% Reduction From Baseline in Mean Plasma Intact Parathyroid Hormone During the Efficacy Assessment Period
Time Frame: Baseline and the efficacy assessment period (EAP), weeks 17 to 20
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Intact parathyroid hormone (iPTH) levels were measured at weeks 17, 18, 19 and 20; the mean value from these measurements was calculated. This endpoint was specified as the the primary endpoint in all countries except the United States (US). In the US this endpoint was specified as a secondary efficacy endpoint. |
Baseline and the efficacy assessment period (EAP), weeks 17 to 20
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Percentage of Participants Who Achieved a Mean iPTH ≤ 300 pg/mL (31.8 Pmol/L) During Weeks 17 to 20
Time Frame: Efficacy assessment period, weeks 17 to 20
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Efficacy assessment period, weeks 17 to 20
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Percent Change in iPTH From Baseline to the Mean Value During Weeks 17 to 20
Time Frame: Baseline and weeks 17 to 20
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Baseline and weeks 17 to 20
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Change in Corrected Serum Calcium From Baseline to the Mean Value During Weeks 17 to 20
Time Frame: Baseline and weeks 17 to 20
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Baseline and weeks 17 to 20
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Change in Serum Phosphorus From Baseline to the Mean Value During Weeks 17 to 20
Time Frame: Baseline and weeks 17 to 20
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Baseline and weeks 17 to 20
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms
- Urologic Diseases
- Endocrine System Diseases
- Renal Insufficiency
- Parathyroid Diseases
- Neoplastic Processes
- Kidney Diseases
- Renal Insufficiency, Chronic
- Hyperparathyroidism
- Neoplasm Metastasis
- Hyperparathyroidism, Secondary
- Physiological Effects of Drugs
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Calcium-Regulating Hormones and Agents
- Calcimimetic Agents
- Cinacalcet
Other Study ID Numbers
- 20130356
- 2013-004958-18 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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