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NCT01464931 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Renal Impairment, sponsored by Amgen.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 7
- Study locations
NCT01464931: Completed Phase 1 study of Renal Impairment, sponsored by Amgen.
NCT01464931 is a Phase 1 study of Renal Impairment that has completed, run by Amgen. The registered enrollment target is 32 participants, roughly in line with the 34-participant average among 32 other Renal Impairment trials with a reported enrollment target. The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01464931, a Phase 1 study of Renal Impairment, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 7
- Study locations
Study 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
Primary Outcome
Clinically significant hypocalcemia is defined as albumin-adjusted calcium \< 7.0 mg/dL or symptomatic hypocalcemia. Symptomatic hypocalcemiais is defined as both a clinical adverse event of hypocalcemia and a concomitant symptom of hypocalcemia (e.g., hypoesthesia, paresthesia, muscle cramps, seizure, prolonged QT interval) that occurred along with the hypocalcemia event or decreased serum calcium levels.
Conditions Studied
Interventions
- DRUG Denosumab
Study Locations (7)
Arizona
- Research Site - Tempe
Colorado
- Research Site - Denver
Florida
- Research Site - Pembroke Pines
Idaho
- Research Site - Meridian
Michigan
- Research Site - Detroit
South Carolina
- Research Site - Orangeburg
Texas
- Research Site - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2011-11 |
| Est. Completion | 2013-03 |
| Phase | Phase 1 |
What the finished NCT01464931 record still lists
NCT01464931 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, roughly in line with the 34-participant average among 32 other Renal Impairment trials with a reported enrollment target.
The record links to 1 condition, with Renal Impairment appearing as the primary indexed condition, and to 1 intervention - of which Denosumab is the first listed.
NCT01464931 lists 7 locations in 7 states (Arizona, Colorado, Florida).
Frequently Asked Questions
What is clinical trial NCT01464931 about?
NCT01464931 is a clinical study titled "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". 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
What is the current status of trial NCT01464931?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2011-11. Estimated completion is 2013-03.
What conditions does trial NCT01464931 study?
This clinical trial studies the following conditions: Renal Impairment.
What interventions are being tested in trial NCT01464931?
The interventions under investigation include: Denosumab (DRUG).
Who is sponsoring clinical trial NCT01464931?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01464931 being conducted?
This trial has 7 study locations across Arizona, Colorado, Florida, Idaho, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Renal Impairment
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01464931's enrollment target sits among peer trials
32 12th of 32 higher than 18 of 32 other Renal Impairment trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Renal Impairment trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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