NCT02138838

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Chronic Kidney Disease, Secondary Hyperparathyroidism

Interventions

Type	Name	Description
DRUG	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.
DIETARY_SUPPLEMENT	Standard of Care	Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.

Timeline

• Start date: 2014-11-07
• Primary completion: 2016-06-23
• Completion: 2016-06-23
• First posted: 2014-05-15
• Last updated: 2020-06-29
• Results posted: 2017-09-14

Locations

60 sites across 16 countries: United States, Belgium, Czechia, France, Germany, Greece, Hungary, Italy, Lithuania, New Zealand, Poland, Portugal, Russia, Slovakia, Spain, Ukraine

Regulatory

• FDA-regulated drug study