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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02138838




Registration number
NCT02138838
Ethics application status
Date submitted
1/04/2014
Date registered
15/05/2014
Date last updated
29/06/2020

Titles & IDs
Public title
Efficacy and Safety of Cinacalcet in Pediatric Patients With Secondary Hyperparathyroidism (SHPT) and Chronic Kidney Disease (CKD) on Dialysis
Scientific title
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
Secondary ID [1] 0 0
2013-004958-18
Secondary ID [2] 0 0
20130356
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease, Secondary Hyperparathyroidism 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cinacalcet HCl
Treatment: Other - Standard of Care

Active comparator: Standard of Care - Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.

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.


Treatment: Drugs: 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.

Treatment: Other: Standard of Care
Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Achieved a = 30% Reduction From Baseline In Mean Plasma iPTH During Weeks 11 to 15
Timepoint [1] 0 0
Baseline and weeks 11 to 15
Primary outcome [2] 0 0
Percentage of Participants Who Achieved a = 30% Reduction From Baseline in Mean Plasma Intact Parathyroid Hormone During the Efficacy Assessment Period
Timepoint [2] 0 0
Baseline and the efficacy assessment period (EAP), weeks 17 to 20
Secondary outcome [1] 0 0
Percentage of Participants Who Achieved a Mean iPTH = 300 pg/mL (31.8 Pmol/L) During Weeks 17 to 20
Timepoint [1] 0 0
Efficacy assessment period, weeks 17 to 20
Secondary outcome [2] 0 0
Percent Change in iPTH From Baseline to the Mean Value During Weeks 17 to 20
Timepoint [2] 0 0
Baseline and weeks 17 to 20
Secondary outcome [3] 0 0
Change in Corrected Serum Calcium From Baseline to the Mean Value During Weeks 17 to 20
Timepoint [3] 0 0
Baseline and weeks 17 to 20
Secondary outcome [4] 0 0
Change in Serum Phosphorus From Baseline to the Mean Value During Weeks 17 to 20
Timepoint [4] 0 0
Baseline and weeks 17 to 20

Eligibility
Key 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
Minimum age
6 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/11/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/06/2016
Sample size
Target
Accrual to date
Final
55
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
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United States of America
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California
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Delaware
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Georgia
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Illinois
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Iowa
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Kentucky
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Maryland
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Massachusetts
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Michigan
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North Carolina
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Ohio
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Pennsylvania
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Texas
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Utah
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Belgium
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Bruxelles
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Belgium
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Gent
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Belgium
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Leuven
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Czechia
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Praha 5
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Bron cedex
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France
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Lille
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France
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Marseille cedex 05
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France
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Nice cedex 3
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France
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Paris
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Hannover
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Germany
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Heidelberg
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Germany
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Marburg
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Greece
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Athens
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Greece
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Thessaloniki
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Hungary
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Budapest
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Hungary
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Szeged
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Genova
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Italy
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Napoli
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Italy
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Torino
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Lithuania
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Vilinus
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New Zealand
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Grafton, Auckland
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Krakow
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Lodz
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Portugal
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Porto
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Russian Federation
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Moscow
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Russian Federation
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Saint Petersburg
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Russian Federation
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Samara
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Kosice
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Spain
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Cataluña
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Ukraine
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Kyiv

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02138838