CompletedPhase 1

A Single-dose Study in Paediatric Patients Aged 2 to Less Than 18 Years With Secondary Hyperparathyroidism (sHPT) Receiving Haemodialysis

United States, Belgium11 participantsStarted 2017-03-14

Plain-language summary

This is a study to evaluate the safety and pharmacokinetics in pediatric patients with secondary hyperparathyroidism receiving a single dose of etelcalcetide at the end of hemodialysis.

Who can participate

Age range2 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subject's parent has provided informed consent and subject has provided assent * Children Age 2 to less than 18 years * Diagnosed with chronic kidney disease * Diagnosed with secondary hyperparathyroidism receiving hemodialysis, * Weighing at least 7 kg * Laboratory results within specified range. Exclusion Criteria: * Currently receiving treatment in another investigation device or drug study * Subject has received cinacalcet therapy within 30 days * History of prolongation QT interval * Subject is taking any medications that are on the QT prolongation medication list * Electrocardiograph (ECG) measurements within specified range.

What they're measuring

Common Treatment-emergent Adverse Events

Timeframe: 30 days

Change From Baseline in Serum Corrected Calcium Concentration Over Time

Timeframe: Baseline and Day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study)

Change From Baseline in Serum Phosphorus Concentration at End of Study

Timeframe: Baseline and day 30 (end of study)

Change From Baseline in Serum Potassium Concentration at End of Study

Timeframe: Baseline and day 30 (end of study)

Change From Baseline in Intact Parathyroid Hormone (iPTH) Levels Over Time

Timeframe: Baseline and day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study)

Change From Baseline in Heart Rate at End of Study

Timeframe: Baseline and day 30 (end of study)

Change From Baseline in Temperature at End of Study

Timeframe: Baseline and day 30 (end of study)

Trial details

NCT IDNCT02833857

SponsorAmgen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-10-31

Results submitted2019-04-23

View on ClinicalTrials.gov More Chronic Kidney Disease, Secondary Hyperparathyroidism trials

Who can participate

Age range2 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Common Treatment-emergent Adverse Events

Timeframe: 30 days

Change From Baseline in Serum Corrected Calcium Concentration Over Time

Timeframe: Baseline and Day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study)

Change From Baseline in Serum Phosphorus Concentration at End of Study

Timeframe: Baseline and day 30 (end of study)

Change From Baseline in Serum Potassium Concentration at End of Study

Timeframe: Baseline and day 30 (end of study)

Change From Baseline in Intact Parathyroid Hormone (iPTH) Levels Over Time

Timeframe: Baseline and day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study)

Change From Baseline in Heart Rate at End of Study

Timeframe: Baseline and day 30 (end of study)

Change From Baseline in Temperature at End of Study

Timeframe: Baseline and day 30 (end of study)