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

Sponsor ID
20110227
Clinicaltrials.gov ID
NCT01833754
EUCTIS ID
N/A
EudraCT ID
N/A

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.

Additional Study Details

Phase
Phase 1
Product
romosozumab
Type
Interventional
Masking
None (Open Label)
Enrollment
24
Additional Study Details

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
Status
Contact Us
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