Study Complete
Sponsor ID
20110227
Study of Romosozumab (AMG 785) Administered to Healthy Participants and Patients with Stage 4 Renal Impairment or Stage 5 Renal Impairment Requiring Hemodialysis
Study Details
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity profile of romosozumab after a single 210 mg subcutaneous dose in healthy participants and patients with stage 4 renal impairment (RI) or stage 5 RI requiring hemodialysis.
Protocol Summary
Primary Outcome Measures
• Subject incidence of treatment-emergent adverse events • Results of safety laboratory tests, vital sign measurements, and ECG measurements • Subject incidence of anti-romosozumab antibodies
Timeframe: 85 days
Secondary Outcome Measures
Romosozumab PK parameters
Timeframe: 15 timepoints, 85 days
Study Documents
Study Synopsis
Available Language(s): English
Locations
Location
Research Site
Denver, CO, United States, 80230
Status
Recruiting
Location
Research Site
Los Angeles, CA, United States, 90022
Status
Recruiting
Location
Research Site
Pembroke Pines, FL, United States, 33028
Status
Recruiting
Location
Research Site
Tempe, AZ, United States, 85284
Status
Recruiting
Location
Research Site
Orangeburg, SC, United States, 29118
Status
Recruiting