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: 27 October 2014
• Main ID: EUCTR2013-004958-18-Outside-EU/EEA
• Date of registration: 22/10/2014
• 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
• Target sample size: 48
• Recruitment status: NA
• 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

Countries of recruitment

Mexico, New Zealand, Russian Federation, Ukraine, 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
XML File Identifier: 2Foe96Pf+yXcUCKoHgnZJBOfL7k=
Page 14/25
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 or potent CYP3A4 inhibitors
(eg, erythromycin, clarithromycin, ketoconazole, itraconazole)
-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


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

Health Condition(s) or Problem(s) studied

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

Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Dialysis
MedDRA version: 17.1 Level: PT Classification code 10020708 Term: Hyperparathyroidism secondary System Organ Class: 10014698 - Endocrine disorders

Intervention(s)

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

Trade Name: Mimpara
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)

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%

Primary end point(s): Achievement of a = 30% reduction from baseline in mean plasma iPTH
during the efficacy assessment period (EAP), defined as Week 17 – 20.

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

Secondary Outcome(s)

Secondary end point(s): • Achievement of a mean iPTH = 300 pg/mL (31.8 pmol/L) during the
EAP
• Percent change in iPTH from baseline to the mean value during the EAP
• Change in corrected total serum calcium from baseline to the mean
value during the EAP
• Change in serum phosphorus from baseline to the mean value during
the EAP

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

Secondary ID(s)

20130356

2013-004958-18-LT

NCT02138838

Source(s) of Monetary Support

Amgen, Inc.