Multiple Dose Study to Evaluate the Safety of Multiple Doses of Denosumab 120mg in Subjects With Severe Chronic Kidney Disease (CKD) and CKD on Dialysis
This study is ongoing, but not recruiting participants.
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01464931
First received: October 17, 2011
Last updated: October 29, 2012
Last verified: October 2012
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Purpose
This is an open-label, multiple-dose study where 30 CKD eligible subjects will receive multiple 120 mg doses of denosumab administered SC; one dose on Day 1 and one dose Day 29.
| Condition | Intervention | Phase |
|---|---|---|
|
Renal Impairment |
Drug: Denosumab |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-label Study to Evaluate the Safety of Multiple Doses of Denosumab 120mg Administered Subcutaneously in Subjects With Severe Chronic Kidney Disease (CKD) and CKD on Dialysis |
Resource links provided by NLM:
Further study details as provided by Amgen:
Primary Outcome Measures:
- Incidence of clinically significant hypocalcemia, defined as albumin-adjusted Ca < 7.0mg/dL or symptomatic hypocalcemia [ Time Frame: 113 days ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Incidence and severity of hypocalcemia, hypomagnesemia and hypophosphatemia as determined by CTCAE v.4.0 criteria [ Time Frame: 113 days ] [ Designated as safety issue: Yes ]
- Laboratory values of albumin-adjusted calcium, magnesium, and phosphorus and their changes compared to baseline [ Time Frame: 113 days ] [ Designated as safety issue: Yes ]
- Adverse events including clinically significant changes in vital signs, physical examinations, clinical laboratory tests, ECGs; [ Time Frame: 113 days ] [ Designated as safety issue: Yes ]
- Serum denosumab and C-telopeptide (CTx) concentrations [ Time Frame: 113 days ] [ Designated as safety issue: No ]
- Incidence of seroreactivity (or antibody positivity) [ Time Frame: 113 days ] [ Designated as safety issue: No ]
| Enrollment: | 32 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Denosumab
All 30 subjects will receive multiple doses of Denosumab
|
Drug: Denosumab
All 30 subjects will receive multiple doses of Denosumab
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subjects at least 18 years old with severe CKD 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01464931
Locations
| United States, Arizona | |
| Research Site | |
| Tempe, Arizona, United States, 85284 | |
| United States, Colorado | |
| Research Site | |
| Denver, Colorado, United States, 80230 | |
| United States, Florida | |
| Research Site | |
| Pembroke Pines, Florida, United States, 33028 | |
| United States, Idaho | |
| Research Site | |
| Meridian, Idaho, United States, 83642 | |
| United States, Michigan | |
| Research Site | |
| Detroit, Michigan, United States, 48236 | |
| United States, South Carolina | |
| Research Site | |
| Orangeburg, South Carolina, United States, 29118 | |
| United States, Texas | |
| Research Site | |
| San Antonio, Texas, United States, 78215 | |
Sponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
More Information
Additional Information:
No publications provided
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT01464931 History of Changes |
| Other Study ID Numbers: | 20101361 |
| Study First Received: | October 17, 2011 |
| Last Updated: | October 29, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Kidney Diseases Renal Insufficiency Renal Insufficiency, Chronic Kidney Failure, Chronic Urologic Diseases |
ClinicalTrials.gov processed this record on May 22, 2013