Phase 1
Completed N=11
A Single-dose Study in Paediatric Patients Aged 2 to Less Than 18 Years With Secondary Hyperparathyroidism (sHPT) Receiving Haemodialysis
Chronic Kidney Disease, Secondary Hyperparathyroidism
Source: ClinicalTrials.gov NCT02833857 ↗
Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcomePrimary: Common Treatment-emergent Adverse Events — 2; 2; 2 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Common Treatment-emergent Adverse Events |
2; 2; 2 | — |
| PRIMARY Change From Baseline in Serum Corrected Calcium Concentration Over Time |
-0.03; -0.03; 0.03; 0.03; -0.01 | — |
| PRIMARY Change From Baseline in Serum Phosphorus Concentration at End of Study |
0.08 | — |
| PRIMARY Change From Baseline in Serum Potassium Concentration at End of Study |
0.45 | — |
| PRIMARY Change From Baseline in Intact Parathyroid Hormone (iPTH) Levels Over Time |
-29.44; -14.81; -10.20; -4.68; -19.81 | — |
| PRIMARY Change From Baseline in Heart Rate at End of Study |
-4.5 | — |
| PRIMARY Change From Baseline in Temperature at End of Study |
0.1 | — |
| PRIMARY Change From Baseline in Blood Pressure at End of Study |
0.2; 3.8 | — |
| PRIMARY Change From Baseline in PR Interval at End of Study |
-3.6 | — |
| PRIMARY Change From Baseline in QRS Interval at End of Study |
-2.6 | — |
| PRIMARY Change From Baseline in QT Interval at End of Study |
2.8 | — |
| PRIMARY Change From Baseline in Corrected (Bazett) QT Interval at End of Study |
-2.1 | — |
| PRIMARY Change From Baseline in Corrected (Fridericia) QT Interval at End of Study |
-0.5 | — |
| SECONDARY Change From Baseline in Serum Total Calcium Concentration |
-0.02; -0.02; 0.03; 0.02; -0.01 | — |
| SECONDARY Change From Baseline in Serum Ionized Calcium Concentration |
-0.05; -0.01; 0.02; 0.01; 0.03 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Etelcalcetide |
50.8 | — |
| SECONDARY Time to Maximum Concentration (Tmax) of Etelcalcetide |
0.17 | — |
| SECONDARY Area Under the Plasma Etelcalcetide Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) |
1360 | — |
| SECONDARY Area Under the Plasma Etelcalcetide Concentration-Time Curve From Time Zero Infinity (AUCinf) |
1700 | — |
| SECONDARY Terminal Half-life (T1/2,z) of Etelcalcetide |
5.77 | — |
| SECONDARY Number of Participants Who Developed Anti-etelcalcetide Binding Antibodies |
2 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events |
6; 2; 0; 0; 0; 0 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02833857). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.