A Multicenter Open-label Extension Study to Assess the Long-term Safety and Efficacy of KAI-4169 (Also Known as AMG 416) in the Treatment of Chronic Kidney Disease-Mineral and Bone Disorder in Patients With Secondary Hyperparathyroidism
Overview
- Phase
- Phase 2
- Intervention
- Etelcalcetide
- Conditions
- Secondary Hyperparathyroidism
- Sponsor
- KAI Pharmaceuticals
- Enrollment
- 30
- Primary Endpoint
- Number of Participants With Adverse Events
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the long term safety and efficacy of thrice weekly intravenous (IV) administration of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in patients receiving hemodialysis who had completed 12 weeks of treatment with etelcalcetide in parent study 20120331 (KAI-4169-005; NCT01414114).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject provides written informed consent.
- •Subject completed the 12 week treatment phase in the parent study study 20120331 ( KAI-4169-005; NCT01414114).
Exclusion Criteria
- •Subject pregnant or nursing
Arms & Interventions
Etelcalcetide
Participants received a bolus IV injection of etelcalcetide 3 times a week (TIW) at the end of each hemodialysis session for up to 144 weeks in the extension study. The starting dose was the same as the final dose administered in the parent study (20120331); the dose was adjusted per protocol-specified guidelines to achieve or maintain parathyroid hormone values in the 150 to 300 pg/mL range.
Intervention: Etelcalcetide
Outcomes
Primary Outcomes
Number of Participants With Adverse Events
Time Frame: From the first dose of study drug in the parent study (20120331) through 30 days after the last dose in the extension study; actual median duration of treatment was 439 days.
Secondary Outcomes
- Percent Change From Baseline in Serum Phosphorus(Baseline and Weeks 13, 26 and 52)
- Percent Change From Baseline in Parathyroid Hormone(Baseline (of the parent study 20120331) and Weeks 13, 26 and 52)
- Percent Change From Baseline in Serum Corrected Calcium(Baseline and Weeks 13, 26 and 52)