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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02138838
Ethics application status
Date submitted
1/04/2014
Date registered
15/05/2014
Date last updated
17/06/2019

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
Other interventions - 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.

Other interventions: 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
Other interventions
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 - 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.
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 - 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.
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
Gender
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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Delaware
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Iowa
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
Mississippi
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Utah
Country [20] 0 0
Belgium
State/province [20] 0 0
Bruxelles
Country [21] 0 0
Belgium
State/province [21] 0 0
Gent
Country [22] 0 0
Belgium
State/province [22] 0 0
Leuven
Country [23] 0 0
Czechia
State/province [23] 0 0
Praha 5
Country [24] 0 0
France
State/province [24] 0 0
Bron cedex
Country [25] 0 0
France
State/province [25] 0 0
Lille
Country [26] 0 0
France
State/province [26] 0 0
Marseille cedex 05
Country [27] 0 0
France
State/province [27] 0 0
Nice cedex 3
Country [28] 0 0
France
State/province [28] 0 0
Paris
Country [29] 0 0
Germany
State/province [29] 0 0
Hannover
Country [30] 0 0
Germany
State/province [30] 0 0
Heidelberg
Country [31] 0 0
Germany
State/province [31] 0 0
Marburg
Country [32] 0 0
Greece
State/province [32] 0 0
Athens
Country [33] 0 0
Greece
State/province [33] 0 0
Thessaloniki
Country [34] 0 0
Hungary
State/province [34] 0 0
Budapest
Country [35] 0 0
Hungary
State/province [35] 0 0
Szeged
Country [36] 0 0
Italy
State/province [36] 0 0
Genova
Country [37] 0 0
Italy
State/province [37] 0 0
Napoli
Country [38] 0 0
Italy
State/province [38] 0 0
Torino
Country [39] 0 0
Lithuania
State/province [39] 0 0
Vilinus
Country [40] 0 0
New Zealand
State/province [40] 0 0
Grafton, Auckland
Country [41] 0 0
Poland
State/province [41] 0 0
Krakow
Country [42] 0 0
Poland
State/province [42] 0 0
Lodz
Country [43] 0 0
Poland
State/province [43] 0 0
Warszawa
Country [44] 0 0
Portugal
State/province [44] 0 0
Porto
Country [45] 0 0
Russian Federation
State/province [45] 0 0
Moscow
Country [46] 0 0
Russian Federation
State/province [46] 0 0
Saint Petersburg
Country [47] 0 0
Russian Federation
State/province [47] 0 0
Samara
Country [48] 0 0
Slovakia
State/province [48] 0 0
Kosice
Country [49] 0 0
Spain
State/province [49] 0 0
Cataluña
Country [50] 0 0
Ukraine
State/province [50] 0 0
Kyiv

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

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective was to evaluate the efficacy of cinacalcet for reducing the plasma
intact parathyroid hormone (iPTH) level by = 30%.
Trial website
https://clinicaltrials.gov/show/NCT02138838
Trial related presentations / publications
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.
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

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02138838