NCT02833857

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

Completed Phase 1 Results posted Last updated 10 July 2019

What this trial tests

Phase 1 trial testing Etelcalcetide in Chronic Kidney Disease, Secondary Hyperparathyroidism in 11 participants. Completed in 31 October 2018.

Timeline

14 March 2017

Primary endpoint
31 October 2018

31 October 2018

Quick facts

Lead sponsor	Amgen
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	11
Start date	14 March 2017
Primary completion	31 October 2018
Estimated completion	31 October 2018
Sites	13 locations across Belgium, United Kingdom, Germany, Poland, Lithuania, United States

Drugs / interventions tested

• Etelcalcetide (ETELCALCETIDE) — full drug profile →

Conditions studied

• Chronic Kidney Disease, Secondary Hyperparathyroidism — all drugs for Chronic Kidney Disease, Secondary Hyperparathyroidism →

Sponsor

Amgen — full company profile →

Who can join

Adults 2 to 17, any sex, with Chronic Kidney Disease, Secondary Hyperparathyroidism. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Common Treatment-emergent Adverse Events Primary · 30 days

A treatment-emergent adverse event is any adverse event (AE) that begins or worsens after the initial dose of study drug (etelcalcetide) and up to 30 days after the last dose. Common adverse events were defined as adverse events occurring in at least 2 participants. The Medical Dictionary for Regulatory Activities (MedDRA) version 21.0 was used for coding all adverse events.

Headache

Group	Value	95% CI
Etelcalcetide	2

Calcium ionised decreased

Group	Value	95% CI
Etelcalcetide	2

Hypotension

Group	Value	95% CI
Etelcalcetide	2

Change From Baseline in Serum Corrected Calcium Concentration Over Time Primary · Baseline and Day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study)

When albumin was less than 4.0 mg/dL, the calcium concentration was corrected according to the formula: cCa (mmol/L) = measured total serum calcium (mmol/L) + 0.02 (40 - serum albumin \[g/L\]).

Day 1, 4 hours

Group	Value	95% CI
Etelcalcetide	-0.03	± 0.12

Day 3

Group	Value	95% CI
Etelcalcetide	-0.03	± 0.08

Day 8

Group	Value	95% CI
Etelcalcetide	0.03	± 0.09

Day 10

Group	Value	95% CI
Etelcalcetide	0.03	± 0.07

Day 30

Group	Value	95% CI
Etelcalcetide	-0.01	± 0.16

Change From Baseline in Serum Phosphorus Concentration at End of Study Primary · Baseline and day 30 (end of study)

Group	Value	95% CI
Etelcalcetide	0.08	± 0.31

Change From Baseline in Serum Potassium Concentration at End of Study Primary · Baseline and day 30 (end of study)

Group	Value	95% CI
Etelcalcetide	0.45	± 1.21

Change From Baseline in Intact Parathyroid Hormone (iPTH) Levels Over Time Primary · Baseline and day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study)

Day 1, 4 hours

Group	Value	95% CI
Etelcalcetide	-29.44	± 37.16

Day 3

Group	Value	95% CI
Etelcalcetide	-14.81	± 37.81

Day 8

Group	Value	95% CI
Etelcalcetide	-10.20	± 38.16

Day 10

Group	Value	95% CI
Etelcalcetide	-4.68	± 37.92

Day 30

Group	Value	95% CI
Etelcalcetide	-19.81	± 51.29

Change From Baseline in Heart Rate at End of Study Primary · Baseline and day 30 (end of study)

Group	Value	95% CI
Etelcalcetide	-4.5	± 9.3

Change From Baseline in Temperature at End of Study Primary · Baseline and day 30 (end of study)

Group	Value	95% CI
Etelcalcetide	0.1	± 0.4

Change From Baseline in Blood Pressure at End of Study Primary · Baseline and day 30 (end of study)

Systolic blood pressure

Group	Value	95% CI
Etelcalcetide	0.2	± 17.5

Diastolic blood pressure

Group	Value	95% CI
Etelcalcetide	3.8	± 8.5

Change From Baseline in PR Interval at End of Study Primary · Baseline and day 30 (end of study)

Group	Value	95% CI
Etelcalcetide	-3.6	± 13.9

Change From Baseline in QRS Interval at End of Study Primary · Baseline and day 30 (end of study)

Group	Value	95% CI
Etelcalcetide	-2.6	± 6.8

Change From Baseline in QT Interval at End of Study Primary · Baseline and day 30 (end of study)

Group	Value	95% CI
Etelcalcetide	2.8	± 21.6

Change From Baseline in Corrected (Bazett) QT Interval at End of Study Primary · Baseline and day 30 (end of study)

Group	Value	95% CI
Etelcalcetide	-2.1	± 32.2

Adverse events — posted to ClinicalTrials.gov

Time frame: 30 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Etelcalcetide

Serious: 0/11 (0%)

Deaths: 0/11

Other adverse events (9 terms — click to expand)

Reaction	System	Etelcalcetide
Calcium ionised decreased	Investigations	—
Headache	Nervous system disorders	—
Hypotension	Vascular disorders	—
Nausea	Gastrointestinal disorders	—
Vomiting	Gastrointestinal disorders	—
Dizziness	Nervous system disorders	—
Paraesthesia	Nervous system disorders	—
Catheter placement	Surgical and medical procedures	—
Gastrostomy	Surgical and medical procedures	—

Data from ClinicalTrials.gov NCT02833857 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Chronic kidney disease in children: an update.
   Cirillo L, De Chiara L, Innocenti S, Errichiello C, et al · · 2023 · cited 25× · PMID 37779846 · DOI 10.1093/ckj/sfad097
2. Phase 1, single-dose study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of etelcalcetide in pediatric patients with secondary hyperparathyroidism receiving hemodialysis.
   Sohn W, Salusky IB, Schmitt CP, Taylan C, et al · · 2021 · PMID 32647975 · DOI 10.1007/s00467-020-04599-z