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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01464931
First received: October 17, 2011
Last updated: December 2, 2015
Last verified: November 2015
  Purpose
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

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 120 mg 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
Participants received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
Drug: Denosumab
Adminstered by subcutaneous injection
Other Names:
  • XGEVA
  • AMG 162

  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 (defined as creatinine clearance < 30 mL/min at both screening assessments) 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: December 2, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases

ClinicalTrials.gov processed this record on February 09, 2016