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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-03-31

Brief Summary

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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

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Detailed Description

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Conditions

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Renal Impairment

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Denosumab

Participants received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.

Group Type EXPERIMENTAL

Denosumab

Intervention Type DRUG

Adminstered by subcutaneous injection

Interventions

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Denosumab

Adminstered by subcutaneous injection

Intervention Type DRUG

Other Intervention Names

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XGEVA AMG 162

Eligibility Criteria

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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