Study Complete
Sponsor ID
20140159

Extension Study of Cinacalcet for Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Patients With Chronic Kidney Disease on Dialysis

Sponsor ID
20140159
Clinicaltrials.gov ID
NCT02341417
EUCTIS ID
N/A
EudraCT ID
2014-003563-38

Study Details

The primary objective of this study was to characterize the long-term safety and tolerability of cinacalcet in pediatric patients with chronic kidney disease (CKD) receiving dialysis.

Additional Study Details

Phase
Phase 3
Product
cinacalcet hcl
Type
Interventional
Masking
None (Open Label)
Enrollment
28
Additional Study Details

Protocol Summary

Primary Outcome Measures

Incidence of treatment-emergent adverse events of interest

Timeframe: between day 1 and up to 30 days after last IP dose

Secondary Outcome Measures

Changes in intact parathyroid hormone (iPTH)

Timeframe: From baseline to Week 15

Changes in intact parathyroid hormone (iPTH)

Timeframe: From baseline to Week 28

Changes in intact parathyroid hormone (iPTH)

Timeframe: From baseline to Week 28

Changes in corrected total serum calcium

Timeframe: From baseline to Week 28

Changes in serum phosphorus

Timeframe: From baseline to Week 28

Changes in intact parathyroid hormone (iPTH)

Timeframe: Week 23 to week 28

Changes in serum corrected calcium (cCa)

Timeframe: From baseline to week 28

Changes in serum phosphorus

Timeframe: From baseline to week 28

Changes in intact parathyroid hormone (iPTH)

Timeframe: From baseline to week 15

Changes in intact parathyroid hormone (iPTH)

Timeframe: From baseline to week 28

Changes in intact parathyroid hormone (iPTH)

Timeframe: From baseline to Week 28/End of Investigational Product

Changes in serum corrected calcium

Timeframe: From baseline to Week 28/End of Investigational Product

Changes in serum phosphorus

Timeframe: From baseline to Week 28/End of Investigational Product

Study Documents

Study Synopsis
Available Language(s): English
Plain Language Summary of Results
Available Language(s): German (Belgium), German, Greek, Hungarian, Italian, Polish, English, Czech, Dutch, French (Belgium), French, Russian, Spanish, Ukrainian

Locations

Location
Status
Contact Us
Location
Research Site
West Orange, NJ, United States, 07052
Status
Completed
Location
Research Site
Praha 5, Czech Republic, 150 06
Status
Completed
Location
Research Site
Cleveland, OH, United States, 44195
Status
Completed
Location
Research Site
Szeged, Hungary, 6720
Status
Completed
Location
Research Site
Krakow, Poland, 30-663
Status
Completed
Location
Research Site
Los Angeles, CA, United States, 90027
Status
Completed
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