Abstract: SA-PO469
Open-Label, Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Etelcalcetide in Subjects Aged 2-<18 Years with sHPT Receiving Maintenance Dialysis
Session Information
- Pediatric Nephrology - II
October 27, 2018 | Location: Exhibit Hall, San Diego Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Pediatric Nephrology
- 1600 Pediatric Nephrology
Authors
- Yan, Lucy, Amgen, San Mateo, California, United States
- Egbuna, Ogo I., Amgen Inc, Thousand Oaks, California, United States
- Schmitt, Claus Peter, Center for Pediatric and Adolescent Medicine, Heidelberg, Germany
- Taylan, Christina, University Hospital of Cologne, Cologne, Germany
- Vande walle, Johan, UZGent, Gent, Belgium
- Ngang, Jude, Amgen Inc, Thousand Oaks, California, United States
- Warady, Bradley A., Children's Mercy Kansas City , Kansas City, Missouri, United States
Background
Approximately 60% to 80% of the paediatric dialysis population receives treatment for secondary HPT with vitamin D. The burden of complications of secondary HPT in the paediatric dialysis population and limitations of current therapy underscore the need for better treatments for secondary HPT in these patients. Etelcalcetide is the only calcimimetic formulated for IV administration and is administered TIW (three times a week) as a bolus dose at the end of the haemodialysis treatment.
Methods
This phase 1 study was conducted to investigate the safety, tolerability, PK and PD characteristics of etelcalcetide after the administration of a single dose that may represent a safe starting dose for this titratable drug to paediatric hemodialysis patients. Subjects (2 to < 18 yrs old) received a single IV dose of 0.035 mg/kg etelcalcetide at the end of a hemodialysis session. Intensive PK and PD samples were collected on Day 1 at 10 min and 4 hours after etelcalcetide administration and for 10 days post dose with a safety follow-up period of up to 30 days post dose.
Results
Six subjects (3M, 3F, 6-15 yrs old) have completed the study. In general, the single dose of etelcalcetide was well tolerated. Adverse events reported during this study were consistent with the known safety profile of etelcalcetide. All corrected calcium levels reported were above 2.25 mmol/L. No clinical symptoms possibly related to hypocalcemia were observed. PK exposure was within the predicted range at this dose level (see Figure below- the dipping point on Day 3 was related to hemodialysis).
Conclusion
Single dose of 0.035 mg/kg etelcalcetide is well tolerated in paediatric patients on hemodialysis. The preliminary PK and safety data collected so far are within the predicted range at this dose level.
See Figure - Plasma Etelcalcetide Concentration (Log) -Time
Funding
- Commercial Support –