A Study to Assess the Efficacy and Safety of Cinacalcet HCl in Pediatric Subjects With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Dialysis

• Register: EUCTR
• Last refreshed on: 8 August 2016
• Main ID: EUCTR2013-004958-18-BE
• Date of registration: 28/07/2014
• Prospective Registration: Yes
• Primary sponsor: Amgen, Inc.
• Public title: A Study to Assess the Efficacy and Safety of Cinacalcet HCl in Pediatric Subjects With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving 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
• Date of first enrolment: 22/10/2014
• Target sample size: 48
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-004958-18
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Standard of care Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Belgium, Czech Republic, France, Germany, Greece, Hungary, Italy, Lithuania, Luxembourg, Mexico, Netherlands, Poland, Portugal, Russian Federation, Slovakia, South Africa, Spain, Switzerland, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: IHQ Medical Info - Clinical Trials
• Affiliation: Amgen (EUROPE) GmbH

• Name: IHQ Medical Info - Clinical Trials
• Affiliation: Amgen (EUROPE) GmbH

Key inclusion & exclusion criteria

Inclusion criteria:
- Subject’s legally acceptable representative has provided informed consent when the subject is legally too young to provide informed consent and the subject has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated.
- Age 6 to < 18 years old at time of randomization
- Diagnosis of CKD, receiving either hemodialysis or peritoneal dialysis for = 30 days prior to screening
- Dry weight = 12.5 kg during screening
- Diagnosis of SHPT with the mean of the 2 consecutive central laboratory iPTH values = 300 pg/mL during screening
- Corrected calcium value = 8.8 mg/dL obtained from the central laboratory during screening
- Dialysate calcium level = 2.5 mEq/L during screening
Are the trial subjects under 18? yes
Number of subjects for this age range: 48
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
- Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s)
- Other investigational procedures while participating in this study are excluded 203 Malignancy except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years
- Subject has known sensitivity to any of the products to be administered during dosing
- Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, electronic patient diary) to the best of the subject and investigator’s knowledge
- History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion
- Subject previously has entered this study
- If sexually active, subject is not willing to use highly effective contraception during treatment and for at least 9 days after the end of treatment
- Subject is pregnant or breast feeding, or planning to become pregnant during the study or within 9 days after the end of treatment
- History of congenital long QT syndrome, second or third degree heart block, ventricular tachyarrythmias or other conditions associated with prolonged QT interval
- Receipt of cinacalcet (within 30 days of screening)
During screening:
- 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, CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole), or CYP2D6 substrates (eg, flecainide, propafenone, metoprolol, desipramine, nortryptiline, clomipramide)
-Use of concomitant medications that may prolong the corrected QT interval (eg, ondansetron, albuterol)
- Receipt of cinacalcet
At time of randomization, scheduled for or expect:
- Renal transplant within 90 days
Within the 60 days prior to randomization:
218 New onset or worsening of a pre-existing seizure disorder
219 Initiation or a change of > 20% in the prescribed dose of growth hormone


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Dialysis
MedDRA version: 18.0 Level: PT Classification code 10020708 Term: Hyperparathyroidism secondary System Organ Class: 10014698 - Endocrine disorders

Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Intervention(s)

Product Name: cincacalet hydrochloride
Product Code: AMG 073
Pharmaceutical Form: Capsule
CAS Number: 364782-34-3
Other descriptive name: CINACALCET HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-

Product Name: Cinacalcet Hydrochloride
Product Code: AMG 073
Pharmaceutical Form: Suspension and effervescent granules for oral suspension
INN or Proposed INN: Cincacalcet
CAS Number: 364782-34-3
Current Sponsor code: AMG 073
Other descriptive name: CINACALCET HYDROCHLORIDE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 0.2-

Product Name: cinacalcet
Product Code: AMG 073
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Cinacalcet
CAS Number: 364782-34-3
Current Sponsor code: AMG 073
Other descriptive name: CINACALCET HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-

Primary Outcome(s)

Primary end point(s): Proportion of patients who achieve a = 30% reduction from baseline in mean plasma iPTH during weeks 17 – 20.

Secondary Objective: • To evaluate the efficacy of cinacalcet for lowering the plasma iPTH level to = 300 pg/mL (31.8 pmol/L)
• To evaluate the impact of cinacalcet on corrected total serum calcium level
• To evaluate the impact of cinacalcet on serum phosphorus level

Main Objective: To evaluate the efficacy of cinacalcet for reducing the plasma intact parathyroid hormone (iPTH) level by = 30%

Timepoint(s) of evaluation of this end point: Week 17 – 20

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Week 17 – 20

Secondary end point(s): • Proportion of patients who achieve a mean iPTH value = 300 pg/mL during weeks 17 to 20
• Percent change in iPTH from baseline to the mean value during weeks 17 to 20
• Change in corrected total serum calcium from baseline to the mean value during weeks 17 to 20
• Change in serum phosphorus from baseline to the mean value during weeks 17 to 20

Secondary ID(s)

2013-004958-18-LT

20130356

Source(s) of Monetary Support

Amgen, Inc.