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 2TerminatedNCT01576146

KAI Pharmaceuticals30 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Secondary Hyperparathyroidism

Interventions

EtelcalcetideDRUG

Administered as an intravenous bolus three times a week at the end of each hemodialysis session at dosages up to a maximum of 15 mg.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

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 Parathyroid Hormone

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.

Time frame: Baseline (of the parent study 20120331) and Weeks 13, 26 and 52

Percent Change From Baseline in Serum Corrected Calcium

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.

Time frame: Baseline and Weeks 13, 26 and 52

Percent Change From Baseline in Serum Phosphorus

Time frame: Baseline and Weeks 13, 26 and 52

Data from ClinicalTrials.gov

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