NCT01439867

Safety & Tolerability of Cinacalcet in Pediatric Patients With Chronic Kidney Disease and Secondary Hyperparathyroidism

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 28 Days – 2189 Days
• Healthy volunteers: Not accepted

Summary

The primary objective was to characterize corrected serum calcium levels on treatment with cinacalcet in pediatric patients with secondary hyperparathyroidism (HPT).

Detailed description

This is a multicenter, 26-week, single-arm, open-label, safety study. Participants were to remain on study for 26 weeks or until time of kidney transplantation, whichever came first. The study and enrollment was placed on partial clinical hold in February 2013 which resulted in changes to the protocol. The study was restarted in April 2014 following these changes. Participants who completed the 26-week study or were on study when the study was closed in June 2016 were eligible to participate in an open-label extension study (Study 20140159; NCT02341417).

Conditions

• Chronic Kidney Disease
• Hyperparathyroidism, Secondary

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.

Timeline

• Start date: 2012-06-22
• Primary completion: 2016-06-03
• Completion: 2016-06-03
• First posted: 2011-09-23
• Last updated: 2020-06-17
• Results posted: 2017-08-11

Locations

42 sites across 13 countries: United States, Belgium, Czechia, France, Germany, Hungary, Italy, Mexico, Netherlands, New Zealand, Poland, Russia, Slovakia