Study to Assess the Impact on Calcium Levels When Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) Switch From Cinacalcet to Etelcalcetide
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|ClinicalTrials.gov Identifier: NCT01932970|
Recruitment Status : Completed
First Posted : August 30, 2013
Results First Posted : April 4, 2017
Last Update Posted : May 16, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hyperparathyroidism, Secondary||Drug: Etelcalcetide||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||158 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Multiple-dose, Single-arm Study to Switch Hemodialysis Subjects With Secondary Hyperparathyroidism From Oral Cinacalcet HCl to Intravenous AMG 416|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||April 2014|
Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks.
Etelcalcetide is provided as a sterile lyophilized powder to be reconstituted with sterile water for injection.
- Percentage of Participants With Serum Corrected Calcium < 7.5 mg/dL During the 4-week Treatment Period [ Time Frame: 4 weeks ]
- Percent Change From Baseline in Parathyroid Hormone During the Treatment Period [ Time Frame: Baseline and weeks 2, 3 and 4 ]
- Percentage of Participants With Serum Corrected Calcium < 8.3 mg/dL During the 4-week Treatment Period [ Time Frame: 4 weeks ]
- Number of Participants With Adverse Events [ Time Frame: From the first dose of study drug up to 30 days after the last dose; 8 weeks ]
- Percentage of Participants With Symptomatic Hypocalcemia During the 4-week Treatment Period [ Time Frame: From the first dose of study drug up to 30 days after the last dose; 8 weeks ]Hpocalcemia was used for events of decreased calcium accompanied by clinical signs and symptoms of hypocalcemia.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01932970
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