CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
Romosozumabdrug
Likely dose
Romosozumab 70 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01833754
NCT01833754Phase 1Completed
CompareCT.gov

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

Amgen·interventional·Posted Apr 17, 2013·Updated Jul 22, 2022

In Brief

A Phase 1 clinical trial evaluating Romosozumab for Osteoporosis. Completed, enrolled 24 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoporosis
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 17, 2013
Enrollment StartApr 22, 2013
Primary CompletionFeb 19, 2014
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 13.2 years ago

Interventions

Romosozumabdrug

Administered as three 70 mg/mL prefilled syringe injections