At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 32 enrolled
Drug / intervention
Denosumabdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Denosumab for Renal Impairment. Completed, enrolled 32 participants across 7 sites.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Impairment
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2011
First PostedNov 2011
Primary CompletionJan 2013
Study CompletionMar 2013
TodayJul 2026
First PostedNov 4, 2011
Enrollment StartNov 1, 2011
Primary CompletionJan 1, 2013
Study CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 14.7 years ago
Interventions
Denosumabdrug
Adminstered by subcutaneous injection