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

Amgen32 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Renal Impairment

Interventions

DenosumabDRUG

Adminstered by subcutaneous injection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

Research Site

Tempe, Arizona, United States

Research Site

Denver, Colorado, United States

Research Site

Pembroke Pines, Florida, United States

Research Site

Meridian, Idaho, United States

Outcomes

Primary Outcomes

Number of Participants With Clinically Significant Hypocalcemia

Clinically significant hypocalcemia is defined as albumin-adjusted calcium \< 7.0 mg/dL or symptomatic hypocalcemia. Symptomatic hypocalcemiais is defined as both a clinical adverse event of hypocalcemia and a concomitant symptom of hypocalcemia (e.g., hypoesthesia, paresthesia, muscle cramps, seizure, prolonged QT interval) that occurred along with the hypocalcemia event or decreased serum calcium levels.

Time frame: 113 days

Secondary Outcomes

Number of Participants With Hypocalcemia Determined by CTCAE v.4.0 Criteria

The severity of hypocalcemia (a low concentration of calcium, corrected for albumin, in the blood) was graded according to the common terminology criteria for adverse events (CTCAE) v.4.0 criteria: Grade 1: albumin-adjusted serum calcium \< lower limit of normal (LLN; 9.2 mg/dL) to 8.0 mg/dL; Grade 2: albumin-adjusted serum calcium \< 8.0 to 7.0 mg/dL; Grade 3: albumin-adjusted serum calcium \< 7.0 to 6.0 mg/dL; Grade 4: albumin-adjusted serum calcium \< 6.0 mg/dL.

Time frame: 113 days

Number of Participants With Hypophosphatemia Determined by CTCAE v.4.0 Criteria

The severity of hypophosphatemia (a low concentration of phosphates in the blood) was graded according to the common terminology criteria for adverse events (CTCAE) v.4.0 criteria: Grade 1: \< LLN (3 mg/dL) - 2.5 mg/dL; Grade 2: \< 2.5 - 2.0 mg/dL; Grade 3: \< 2.0 - 1.0 mg/dL; Grade 4: \< 1.0 mg/dL.

Time frame: 113 days

Number of Participants With Hypomagnesemia Determined by CTCAE v.4.0 Criteria

The severity of hypomagnesemia (a low concentration of magnesium in the blood) was graded according to the common terminology criteria for adverse events (CTCAE) v.4.0 criteria: Grade 1: \< LLN (1.5 mg/dL) - 1.2 mg/dL; Grade 2: \< 1.2 - 0.9 mg/dL; Grade 3: \< 0.9 - 0.7 mg/dL; Grade 4: \< 0.7 mg/dL.

Time frame: 113 days

Data from ClinicalTrials.gov

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Number of Participants With Adverse Events

The severity of each adverse event (AE) was graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. The investigator assessed whether AEs were possibly related to study drug by answering the question: "Is there a reasonable possibility that the event may have been caused by the investigational product?" Abnormal laboratory findings without clinical significance (based on the investigator's judgment) were not recorded as AEs, however, laboratory value changes that required treatment or adjustment in current therapy were considered AEs. A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal, • life-threatening (places the participant at immediate risk of death), • requires in-patient hospitalization or prolongation of existing hospitalization, • results in persistent or significant disability/incapacity, • congenital anomaly/birth defect, and/or • other medically important serious event.

Time frame: 113 days