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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01439867




Registration number
NCT01439867
Ethics application status
Date submitted
22/09/2011
Date registered
23/09/2011
Date last updated
17/06/2020

Titles & IDs
Public title
Safety & Tolerability of Cinacalcet in Pediatric Patients With Chronic Kidney Disease and Secondary Hyperparathyroidism
Scientific title
An Open-label, Single-arm Study to Assess the Safety & Tolerability of Cinacalcet in Addition to Standard of Care in Pediatric Subjects Age 28 Days to < 6 Yrs With Chronic Kidney Disease & Secondary Hyperparathyroidism Receiving Dialysis
Secondary ID [1] 0 0
2011-004618-40
Secondary ID [2] 0 0
20110100
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease 0 0
Hyperparathyroidism, Secondary 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 hydrochloride
Treatment: Drugs - Standard of Care

Experimental: Cinacalcet - Prior to the partial clinical hold, the starting dose was 0.25 mg/kg (based on dry weight) and was titrated upwards (maximum allowed daily dose of 4.2 mg/kg) based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms.

After the partial clinical hold the starting dose was 0.20 mg/kg (based on dry weight) and was titrated upwards (maximum allowed daily dose of 2.5 or 60 mg, whichever was lower) based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms.

All participants also received standard of care, which may have included vitamin D sterols.


Treatment: Drugs: Cinacalcet hydrochloride
Cinacalcet was provided as 5 mg capsules that were opened, and the contents were either sprinkled on soft food or suspended into a sucrose syrup to create a liquid suspension for administration. All doses were administered with food or shortly after a meal at the same time daily.

Treatment: Drugs: Standard of Care
Standard of care may have included vitamin D sterols (25 OH vitamin D and/or 1-25 OH vitamin D and its analogs) at the discretion of the investigator.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Hypocalcemia
Timepoint [1] 0 0
26 weeks
Secondary outcome [1] 0 0
Percentage of Participants With Corrected Serum Calcium Levels < 8.8 mg/dL (2.2 mmol/L) During the Study
Timepoint [1] 0 0
26 weeks
Secondary outcome [2] 0 0
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Timepoint [2] 0 0
Baseline and weeks 3, 7, 11, 15, 19, 22, and 24
Secondary outcome [3] 0 0
Percent Change From Baseline in Corrected Serum Calcium
Timepoint [3] 0 0
Baseline and weeks 3, 7, 11, 15, 19, 22, and 24
Secondary outcome [4] 0 0
Percent Change From Baseline in Serum Phosphorous
Timepoint [4] 0 0
Baseline and weeks 3, 7, 11, 15, 19, 22, and 24
Secondary outcome [5] 0 0
Percent Change From Baseline in Calcium Phosphorus Product (Ca x P)
Timepoint [5] 0 0
Baseline and weeks 3, 7, 11, 15, 19, 22, and 24
Secondary outcome [6] 0 0
Percentage of Participants Who Achieved > 30% Reduction in iPTH From Baseline at Any Two Consecutive Measurements
Timepoint [6] 0 0
26 weeks
Secondary outcome [7] 0 0
Percentage of Participants Who Achieved = 30% Reduction in iPTH From Baseline During the Study
Timepoint [7] 0 0
26 weeks
Secondary outcome [8] 0 0
Percentage of Participants Who Achieved iPTH Values Between 200 and 300 pg/mL at Any Two Consecutive Measurements
Timepoint [8] 0 0
26 weeks
Secondary outcome [9] 0 0
Percentage of Participants Who Achieved iPTH Values < 300 pg/mL During the Study
Timepoint [9] 0 0
26 weeks
Secondary outcome [10] 0 0
Dose- and Weight-Normalized Maximum Plasma Concentration (Cmax) of Cinacalcet
Timepoint [10] 0 0
Week 12
Secondary outcome [11] 0 0
Dose- and Weight-Normalized Area Under the Plasma Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration (AUClast) for Cinacalcet
Timepoint [11] 0 0
Week 12

Eligibility
Key inclusion criteria
Inclusion criteria:

* Subjects between the ages of 28 days to < 6 years of age at enrollment (Czech Republic minimum age is = 2 years of age at enrollment)
* Screening plasma iPTH level > 300 pg/mL (31.8 pmol/L) from the central laboratory, and not have received any cinacalcet therapy for at least 30 days prior to start of dosing
* Screening corrected calcium from the central laboratory:
* = 9.4 mg/dL (2.35 mmol/L) if age 28 days to < 2 years
* = 8.8 (2.2 mmol/L) if age = 2 to < 6 years
* Serum phosphorus from the central laboratory:
* = 5.0 mg/dL (1.25 mmol/L) if age 28 days to < 1 year
* = 4.5 mg/dL (1.13 mmol/L) if age = 1 to < 6 years
* SHPT not due to vitamin D deficiency, per investigator assessment
* Dry weight = 7 kg at the time of screening
Minimum age
28 Days
Maximum age
2189 Days
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criterion:

* 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 CYP 3A4 inhibitors (e.g., erythromycin, clarithromycin, ketoconazole, itraconazole)
* Use of concomitant medications that may prolong the QTc interval (e.g., ondansetron, albuterol)

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
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
Single group
Other design features
Phase
Phase 2
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
22/06/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/06/2016
Sample size
Target
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Iowa
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Oklahoma
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
Belgium
State/province [15] 0 0
Bruxelles
Country [16] 0 0
Belgium
State/province [16] 0 0
Gent
Country [17] 0 0
Belgium
State/province [17] 0 0
Leuven
Country [18] 0 0
Czechia
State/province [18] 0 0
Praha 5
Country [19] 0 0
France
State/province [19] 0 0
Bron cedex
Country [20] 0 0
France
State/province [20] 0 0
Lille
Country [21] 0 0
France
State/province [21] 0 0
Paris
Country [22] 0 0
Germany
State/province [22] 0 0
Heidelberg
Country [23] 0 0
Hungary
State/province [23] 0 0
Budapest
Country [24] 0 0
Hungary
State/province [24] 0 0
Debrecen
Country [25] 0 0
Hungary
State/province [25] 0 0
Szeged
Country [26] 0 0
Italy
State/province [26] 0 0
Genova
Country [27] 0 0
Italy
State/province [27] 0 0
Roma
Country [28] 0 0
Italy
State/province [28] 0 0
Torino
Country [29] 0 0
Mexico
State/province [29] 0 0
Chihuahua
Country [30] 0 0
Netherlands
State/province [30] 0 0
Amsterdam
Country [31] 0 0
New Zealand
State/province [31] 0 0
Grafton, Auckland
Country [32] 0 0
Poland
State/province [32] 0 0
Gdansk
Country [33] 0 0
Poland
State/province [33] 0 0
Krakow
Country [34] 0 0
Poland
State/province [34] 0 0
Warszawa
Country [35] 0 0
Russian Federation
State/province [35] 0 0
Moscow
Country [36] 0 0
Russian Federation
State/province [36] 0 0
Saint Petersburg
Country [37] 0 0
Slovakia
State/province [37] 0 0
Kosice

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/NCT01439867