Chronic Kidney Disease Clinical Trial
Official title:
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
The primary objective was to characterize corrected serum calcium levels on treatment with cinacalcet in pediatric patients with secondary hyperparathyroidism (HPT).
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).
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