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
Information source: Amgen
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Renal Impairment
Intervention: Denosumab (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Amgen Official(s) and/or principal investigator(s): MD, Study Director, Affiliation: Amgen
Summary
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.
Clinical Details
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
Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Incidence of clinically significant hypocalcemia, defined as albumin-adjusted Ca < 7.0mg/dL or symptomatic hypocalcemia
Secondary outcome: Incidence and severity of hypocalcemia, hypomagnesemia and hypophosphatemia as determined by CTCAE v.4.0 criteriaLaboratory values of albumin-adjusted calcium, magnesium, and phosphorus and their changes compared to baseline Adverse events including clinically significant changes in vital signs, physical examinations, clinical laboratory tests, ECGs; Serum denosumab and C-telopeptide (CTx) concentrations Incidence of seroreactivity (or antibody positivity)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Research Site, Tempe, Arizona 85284, United States
Research Site, Denver, Colorado 80230, United States
Research Site, Pembroke Pines, Florida 33028, United States
Research Site, Meridian, Idaho 83642, United States
Research Site, Detroit, Michigan 48236, United States
Research Site, Orangeburg, South Carolina 29118, United States
Research Site, San Antonio, Texas 78215, United States
Additional Information
AmgenTrials clinical trials website
Starting date: November 2011
Last updated: November 26, 2013
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