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
  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: 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: November 2011
Study Completion Date: March 2013
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: November 26, 2013
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 April 15, 2014