Clinical trial NCT01464931: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Impairment
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2011-11-04
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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


Eligibility 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

Primary outcomes:
measure: Number of Participants With Clinically Significant Hypocalcemia
timeFrame: 113 days
Secondary outcomes:
measure: Number of Participants With Hypocalcemia Determined by CTCAE v.4.0 Criteria
timeFrame: 113 days
measure: Number of Participants With Hypophosphatemia Determined by CTCAE v.4.0 Criteria
timeFrame: 113 days
measure: Number of Participants With Hypomagnesemia Determined by CTCAE v.4.0 Criteria
timeFrame: 113 days
measure: Percent Change From Baseline in Albumin-adjusted Serum Calcium Over Time
timeFrame: Baseline and Days 2, 3, 6, 8, 11, 15, 22, 29, 30, 31, 34, 36, 39, 43, 57, 71, 85, and 113
measure: Percent Change From Baseline in Serum Phosphorus Over Time
timeFrame: Baseline and Days 2, 3, 6, 8, 11, 15, 22, 29, 30, 31, 34, 36, 39, 43, 57, 71, 85, and 113
measure: Percent Change From Baseline in Serum Magnesium Over Time
timeFrame: Baseline and Days 2, 3, 6, 8, 11, 15, 22, 29, 30, 31, 34, 36, 39, 43, 57, 71, 85, and 113
measure: Number of Participants With Adverse Events
timeFrame: 113 days
measure: Maximum Observed Serum Denosumab Concentration (Cmax)
timeFrame: Days 1 and 29 (predose), and on Days 8, 15, 36, 43, 57, 71, 85, and 113
measure: Time to Maximum Observed Serum Denosumab Concentration (Tmax)
timeFrame: Days 1 and 29 (predose), and on Days 8, 15, 36, 43, 57, 71, 85, and 113
measure: Area Under the Serum Concentration-time Curve From Time 0 to 4 Weeks (AUC0-4wks) After Dose 1
timeFrame: Days 1, 8, 15, and 29 (predose)
measure: Area Under the Serum Concentration-time Curve From Time 0 to 12 Weeks (AUC0-12wks) After Dose 2
timeFrame: Days 29 (predose), 36, 43, 57, 71, and 85
measure: Percent Change From Baseline in Serum C-Telopeptide Over Time
timeFrame: Baseline and Days 1 and 29 (predose), and on Days 8, 15, 36, 43, 57, 71, 85, and 113
measure: Number of Participants Who Developed Anti-denosumab Antibodies
timeFrame: From Day 1 (predose) to Day 113
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Research Site
state: Arizona
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Pembroke Pines
country: United States
facility: Research Site
state: Florida
city: Meridian
country: United States
facility: Research Site
state: Idaho
city: Detroit
country: United States
facility: Research Site
state: Michigan
city: Orangeburg
country: United States
facility: Research Site
state: South Carolina
city: San Antonio
country: United States
facility: Research Site
state: Texas
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: