Efficacy and Safety of Cinacalcet in Pediatric Patients With Secondary Hyperparathyroidism (SHPT) and Chronic Kidney Disease (CKD) on Dialysis

Amgen

Status and phase: Terminated; Phase 3

Conditions: Chronic Kidney Disease, Secondary Hyperparathyroidism

Treatments: Drug: Cinacalcet HCl; Dietary Supplement: Standard of Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT02138838

20130356

2013-004958-18 (EudraCT Number)

Details and patient eligibility

About

The primary objective was to evaluate the efficacy of cinacalcet for reducing the plasma intact parathyroid hormone (iPTH) level by ≥ 30%.

Full description

This was a 24-week, randomized, multicenter, open-label, controlled study. Participants were randomized into one of two treatment arms; oral administration of cinacalcet daily in addition to standard of care treatment, or standard of care alone. Randomization was stratified by age group (6 to < 12 and 12 to < 18 years of age). All participants received standard of care which could include therapy with Vitamin D sterols, calcium supplementation, and phosphate binders.

Participants in both treatment groups who completed the 20-week treatment period and those who ended the study due to study closure were eligible to enroll in an open-label extension study (20140159; NCT02341417) for further safety follow-up.

Enrollment: 55 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 2 patient groups

Standard of Care

Active Comparator group

Description:

Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.

Treatment:

Dietary Supplement: Standard of Care

Cinacalcet

Experimental group

Description:

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:

Dietary Supplement: Standard of Care

Drug: Cinacalcet HCl