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NCT01833754 · ClinicalTrials.gov registry record · Phase 1

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 study, sponsored by Amgen.

Completed
Registry status
Phase 1
Development phase
24
Enrollment target

NCT01833754 is a Phase 1 study that has completed, run by Amgen. The registered enrollment target is 24 participants.

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The verdict

NCT01833754, a Phase 1 study, has completed, sponsored by Amgen.

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target

Study 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.

Interventions

  • DRUG Romosozumab

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2013-04-22
Est. Completion 2014-02-19
Phase Phase 1

Sponsor

Amgen

558 total trials

What the Registry Record Tells You About NCT01833754

The ClinicalTrials.gov registry entry for NCT01833754 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Romosozumab is the first listed.

NCT01833754 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01833754 about?

NCT01833754 is a clinical study titled "Study of Romosozumab (AMG 785) Administered to Healthy Participants and Patients With Stage 4 Renal Impairment or Stage 5 Renal Impairment Requiring Hemodialysis". 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.

What is the current status of trial NCT01833754?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2013-04-22. Estimated completion is 2014-02-19.

What interventions are being tested in trial NCT01833754?

The interventions under investigation include: Romosozumab (DRUG).

Who is sponsoring clinical trial NCT01833754?

This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.