Phase 1
Completed N=32
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
Source: ClinicalTrials.gov NCT01464931 ↗Enrolled (actual)
32
Serious AEs
9.4%
Results posted
Feb 2016
Primary outcomePrimary: Number of Participants With Clinically Significant Hypocalcemia — 1; 2 participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Clinically Significant Hypocalcemia |
1; 2 | — |
| SECONDARY Number of Participants With Hypocalcemia Determined by CTCAE v.4.0 Criteria |
12; 6; 3; 9; 0; 1 | — |
| SECONDARY Number of Participants With Hypophosphatemia Determined by CTCAE v.4.0 Criteria |
0; 0; 2; 1; 0; 5 | — |
| SECONDARY Number of Participants With Hypomagnesemia Determined by CTCAE v.4.0 Criteria |
2; 0; 0; 0; 0; 0 | — |
| SECONDARY Percent Change From Baseline in Albumin-adjusted Serum Calcium Over Time |
-0.55; 1.21; -3.20; -1.86; -4.27; -7.34 | — |
| SECONDARY Percent Change From Baseline in Serum Phosphorus Over Time |
-5.97; -20.00; -10.37; -25.93; -19.09; -24.56 | — |
| SECONDARY Percent Change From Baseline in Serum Magnesium Over Time |
0.00; -3.85; 0.00; 0.00; 2.50; 4.00 | — |
| SECONDARY Number of Participants With Adverse Events |
10; 15; 3; 7; 1; 2 | — |
| SECONDARY Maximum Observed Serum Denosumab Concentration (Cmax) |
10.5; 8.17; 16.1; 14.5 | — |
| SECONDARY Time to Maximum Observed Serum Denosumab Concentration (Tmax) |
14; 14; 14; 7.0 | — |
| SECONDARY Area Under the Serum Concentration-time Curve From Time 0 to 4 Weeks (AUC0-4wks) After Dose 1 |
233; 177 | — |
| SECONDARY Area Under the Serum Concentration-time Curve From Time 0 to 12 Weeks (AUC0-12wks) After Dose 2 |
853; 607 | — |
| SECONDARY Percent Change From Baseline in Serum C-Telopeptide Over Time |
-63.0; -79.1; -60.7; -79.3; -58.4; -81.5 | — |
| SECONDARY Number of Participants Who Developed Anti-denosumab Antibodies |
0; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01464931). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.