drugset / Trial / 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

NCT01464931

Phase 1 Completed 32 enrolled Amgen
NaSingle-groupOpen-labelTreatment

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

Timeline

Start
2011-11
Primary completion
2013-01
Completion
2013-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Denosumab Monoclonal antibody 120 mg Subcutaneous