Status:
COMPLETED
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
Lead Sponsor:
Amgen
Conditions:
Renal Impairment
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Subjects must have calcium, phosphate, and magnesium levels appropriate for their condition and must not have other uncontrolled co-morbidities.
- Additional exclusion criteria apply
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01464931
Start Date
November 1 2011
End Date
March 1 2013
Last Update
February 19 2016
Active Locations (7)
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1
Research Site
Tempe, Arizona, United States, 85284
2
Research Site
Denver, Colorado, United States, 80230
3
Research Site
Pembroke Pines, Florida, United States, 33028
4
Research Site
Meridian, Idaho, United States, 83642