Study Complete
Sponsor ID
20101361
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
Study Details
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
Protocol Summary
Primary Outcome Measures
Incidence of clinically significant hypocalcemia, defined as albumin-adjusted Ca < 7.0mg/dL or symptomatic hypocalcemia
Timeframe: 113 days
Secondary Outcome Measures
Incidence and severity of hypocalcemia, hypomagnesemia and hypophosphatemia as determined by CTCAE v.4.0 criteria
Timeframe: 113 days
Laboratory values of albumin-adjusted calcium, magnesium, and phosphorus and their changes compared to baseline
Timeframe: 113 days
Adverse events including clinically significant changes in vital signs, physical examinations, clinical laboratory tests, ECGs;
Timeframe: 113 days
Serum denosumab and C-telopeptide (CTx) concentrations
Timeframe: 113 days
Incidence of seroreactivity (or antibody positivity)
Timeframe: 113 days
Locations
Location
Research Site
Denver, CO, United States, 80230
Status
Recruiting
Location
Research Site
Pembroke Pines, FL, United States, 33028
Status
Recruiting
Location
Research Site
Detroit, MI, United States, 48236
Status
Completed
Location
Research Site
San Antonio, TX, United States, 78215
Status
Recruiting
Location
Research Site
Tempe, AZ, United States, 85284
Status
Completed
Location
Research Site
Orangeburg, SC, United States, 29118
Status
Completed
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