NCT01833754

Study of Romosozumab (AMG 785) Administered to Healthy Participants and Patients With Stage 4 Renal Impairment or Stage 5 Renal Impairment Requiring Hemodialysis

A Phase 1, Open-label, Single-dose Study of Romosozumab (AMG 785) Administered Subcutaneously to Healthy Subjects and Subjects With Stage 4 Renal Impairment or Stage 5 Renal Impairment Requiring Hemodialysis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Osteoporosis

Interventions

Type	Name	Description
DRUG	Romosozumab	Administered as three 70 mg/mL prefilled syringe injections

Timeline

• Start date: 2013-04-22
• Primary completion: 2014-02-19
• Completion: 2014-02-19
• First posted: 2013-04-17
• Last updated: 2022-07-22
• Results posted: 2019-02-25

Locations

5 sites across 1 country: United States