NCT01464931

Multiple Dose Study to Evaluate the Safety of Multiple Doses of Denosumab 120 mg in Adults With Severe Chronic Kidney Disease (CKD) and CKD on Dialysis

An Open-label Study to Evaluate the Safety of Multiple Doses of Denosumab 120 mg Administered Subcutaneously in Subjects With Severe Chronic Kidney Disease (CKD) and CKD on Dialysis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective was to evaluate the incidence of clinically significant hypocalcemia following multiple 120 mg subcutaneous doses of denosumab in patients with severe chronic kidney disease (CKD) and CKD on dialysis

Conditions

• Renal Impairment

Interventions

Type	Name	Description
DRUG	Denosumab	Adminstered by subcutaneous injection

Timeline

• Start date: 2011-11-01
• Primary completion: 2013-01-01
• Completion: 2013-03-01
• First posted: 2011-11-04
• Last updated: 2016-02-19
• Results posted: 2016-02-19

Locations

7 sites across 1 country: United States