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

Amgen

Status and phase: Completed; Phase 1

Conditions: Renal Impairment

Treatments: Drug: Denosumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01464931

20101361

Details and patient eligibility

About

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

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Denosumab

Experimental group

Description:

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

Treatment:

Drug: Denosumab