Study to Assess the Impact on Calcium Levels When Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) Switch From Cinacalcet to Etelcalcetide

• Status: Completed
• Trial end date: 2017-02-14
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter, multiple-dose, single-arm, open-label study to assess the impact on serum corrected calcium levels when switching patients from cinacalcet to etelcalcetide (AMG 416).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Cinacalcet Hydrochloride

Criteria

Inclusion Criteria

• Subject is 18 years of age or older at the time of informed consent.

• Subject must be receiving maintenance hemodialysis 3 times weekly for at least 8 weeks.

• Subject must have SHPT as defined by having a mean of 3 consecutive central laboratory screening predialysis serum parathyroid hormone (PTH) values ≥ 200 pg/mL, with measurements obtained from 3 different calendar weeks in the 4-week screening period while receiving cinacalcet.

• Subject must have a mean of 3 consecutive central laboratory screening predialysis serum corrected calcium (cCa) values ≥ 7.5 mg/dL, with measurements obtained from 3 different calendar weeks in the 4-week screening period while receiving cinacalcet.

• Subject must be on a stable dose of cinacalcet before screening (defined as no dose change within the 4 weeks prior to screening).

• Other Inclusion Criteria may apply.

Exclusion Criteria

• Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s).

• Subject has received AMG 416 in a prior clinical trial of AMG 416 (also known as KAI-4169).

• Subject has known sensitivity to any of the products or components of AMG 416 to be administered during dosing.

• Subject is unwilling to use effective contraception during the study, and for women, up to a period of up to 3 months after the last dose of AMG 416.

• Subject is pregnant or nursing.

• Anticipated or scheduled parathyroidectomy during the study period.

• Subject has received a parathyroidectomy within 6 months prior to dosing.

• Other Exclusion Criteria may apply.