Study to Assess the Impact on Calcium Levels When Hemodialysis Patients With Secondary Hyperparat… (NCT01932970) | Clinical Trial Compass
CompletedPhase 3
Study to Assess the Impact on Calcium Levels When Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) Switch From Cinacalcet to Etelcalcetide
United States158 participantsStarted 2013-08-12
Plain-language 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).
Who can participate
Age range18 Years – 100 Years
SexALL
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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 sched…
What they're measuring
1
Percentage of Participants With Serum Corrected Calcium < 7.5 mg/dL During the 4-week Treatment Period