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

Completed · Phase 1

Conditions studied: Renal Impairment

In brief

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

Key facts

Study ID

NCT01464931

Run by

Amgen

People needed

32

Starts

2011-11-01

Expected to finish

2013-03-01

Last updated by the study team

2016-02-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects at least 18 years old with severe CKD (defined as creatinine clearance < 30 mL/min at both screening assessments) and CKD requiring hemodialysis
• Additional inclusion criteria apply

You may not qualify if…

• Subjects must have calcium, phosphate, and magnesium levels appropriate for their condition and must not have other uncontrolled co-morbidities.
• Additional exclusion criteria apply

Where it is running

• Research Site — Tempe, Arizona, United States
• Research Site — Denver, Colorado, United States
• Research Site — Pembroke Pines, Florida, United States
• Research Site — Meridian, Idaho, United States
• Research Site — Detroit, Michigan, United States
• Research Site — Orangeburg, South Carolina, United States
• Research Site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.