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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01464931
First received: October 17, 2011
Last updated: November 26, 2013
Last verified: November 2013

October 17, 2011
November 26, 2013
November 2011
January 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01464931 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Renal Impairment
Drug: Denosumab
All 30 subjects will receive multiple doses of Denosumab
Experimental: Denosumab
All 30 subjects will receive multiple doses of Denosumab
Intervention: Drug: Denosumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
March 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01464931
20101361
No
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP