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
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | November 2011 |
| End Date: | March 2013 |
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
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
following multiple 120 mg subcutaneous doses of denosumab in patients with severe chronic
kidney disease (CKD) and CKD on dialysis
Inclusion Criteria:
- 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 Criteria:
- Subjects must have calcium, phosphate, and magnesium levels appropriate for their
condition and must not have other uncontrolled co-morbidities.
- Additional exclusion criteria apply
We found this trial at
7
sites
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