Study identification

PURI

https://redirect.ema.europa.eu/resource/17576

EU PAS number

EUPAS5647

Study ID

17576

Official title and acronym

A Prospective Cohort Study to Describe Use and Safety of Cinacalcet in Pediatric Patients Receiving Dialysis in the NAPRTCS Registry (20120116)

DARWIN EU® study

No

Study countries

Canada
Costa Rica
Mexico
United States

Study description

Describe the demographics, laboratory values, and secondary hyperparathyroidism (SHPT) medication use (specifically cinacalcet), and the occurrence of hypocalcemia, seizures, and infections (requiring hospitalization), in cinacalcet treated and untreated patients enrolled in the North American Pediatric Renal Trials and Collaborative Studies (NAPRTCS) receiving dialysis for chronic kidney disease (CKD).

Study status

Finalised
Research institutions and networks

Institutions

Amgen
United States
First published:
21/02/2024
Institution
North American Pediatric Renal Trials and Collaborative Studies Boston, MA, USA

Contact details

Global Development Leader Amgen, Inc

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Data analysis start date

Actual:

Date of interim report, if expected

Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Amgen
Study protocol
Initial protocol
English (284.36 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable