Chronic Kidney Disease, Secondary Hyperparathyroidism Clinical Trial
Official 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
The primary objective was to evaluate the efficacy of cinacalcet for reducing the plasma intact parathyroid hormone (iPTH) level by ≥ 30%.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02833857 -
A Single-dose Study in Paediatric Patients Aged 2 to Less Than 18 Years With Secondary Hyperparathyroidism (sHPT) Receiving Haemodialysis
|
Phase 1 |