Open-label Study to Assess the Long-term Safety and Efficacy of Etelcalcetide (Also Known as AMG 416 or KAI-4169) in Patients With Secondary Hyperparathyroidism

Phase 2

Terminated

• Conditions: Secondary Hyperparathyroidism
• Interventions: Drug: Etelcalcetide

• Registration Number: NCT01576146
• Lead Sponsor: KAI Pharmaceuticals

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-04-05
• Study First Submitted QC: 2012-04-10
• Study First Posted: 2012-04-12
• Primary Completion: 2014-05-01
• Study Completion: 2014-05-01
• Disposition First Submitted: 2015-07-21
• Disposition First Submitted QC: 2015-07-21
• Disposition First Posted: 2015-08-11
• Status Verified: 2017-03
• Results First Submitted: 2017-03-01
• Results First Submitted QC: 2017-03-01
• Last Update Submitted: 2017-03-01
• Results First Posted: 2017-04-13
• Last Update Posted: 2017-04-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Etelcalcetide	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	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 Outcome Measures

Name	Time	Method
Percent Change From Baseline in Serum Phosphorus	Baseline and Weeks 13, 26 and 52	Baseline was defined as the average of 3 predialysis results obtained within 3 weeks before the first dose of study drug in the parent study (20120331).; The week numbering for this study continued from the parent study 20120331; the first measurement for all parameters in the extension study started at week 13.
Percent Change From Baseline in Parathyroid Hormone	Baseline (of the parent study 20120331) and Weeks 13, 26 and 52	Baseline was defined as the average of 3 predialysis results obtained within 3 weeks before the first dose of etelcalcetide in the parent study (20120331).; The week numbering for this study continued from the parent study 20120331 hence the first measurement for all parameters in the extension study started at week 13.
Percent Change From Baseline in Serum Corrected Calcium	Baseline and Weeks 13, 26 and 52	Baseline was defined as the average of 3 predialysis results obtained within 3 weeks before the first dose of study drug in the parent study (20120331).; The week numbering for this study continued from the parent study 20120331; the first measurement for all parameters in the extension study started at week 13.