Study of Romosozumab (AMG 785) Administered to Healthy Participants and Patients With Stage 4 Renal Impairment or Stage 5 Renal Impairment Requiring Hemodialysis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-22

Study Completion Date

2014-02-19

Brief Summary

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The purpose of this study is to evaluate the safety, tolerability, and immunogenicity profile of romosozumab after a single 210 mg subcutaneous dose in healthy participants and patients with stage 4 renal impairment (RI) or stage 5 RI requiring hemodialysis.

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Detailed Description

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Conditions

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Osteoporosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1: Stage 4 Renal Impairment

Participants with stage 4 renal impairment (defined as an estimated glomerular filtration rate \[eGFR\] 15 to 29 mL/min/1.73 m²) received a single subcutaneous injection of 210 mg romosozumab on day 1.

Group Type EXPERIMENTAL

Romosozumab

Intervention Type DRUG

Administered as three 70 mg/mL prefilled syringe injections

Group 2: ESRD Requiring Hemodialysis

Participants with end stage renal disease (ESRD) requiring hemodialysis received a single subcutaneous injection of 210 mg romosozumab on day 1.

Group Type EXPERIMENTAL

Romosozumab

Intervention Type DRUG

Administered as three 70 mg/mL prefilled syringe injections

Group 3: Healthy Participants

Healthy participants (eGFR ≥ 80 mL/min/1.73 m²) received a single subcutaneous injection of 210 mg romosozumab on day 1.

Group Type EXPERIMENTAL

Romosozumab

Intervention Type DRUG

Administered as three 70 mg/mL prefilled syringe injections

Interventions

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Romosozumab

Administered as three 70 mg/mL prefilled syringe injections

Intervention Type DRUG

Other Intervention Names

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AMG 785 EVENITY™

Eligibility Criteria

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Inclusion Criteria

* Males or females ≥ 50 years of age
* Body weight ≥ 45 and ≤ 110 kg
* Willing to adhere to calcium and vitamin D supplementation requirements
* Females must be of non-reproductive potential

* Group 1 - Stage 4 RI (estimated glomerular filtration rate (eGFR) 15-29 mL/min/1.73 m²)
* Group 2 - End stage renal disease requiring hemodialysis

• Renal function defined as an estimated glomerular filtration rate (eGFR) ≥ 80 mL/min/1.73 m²

Exclusion Criteria

* History of metabolic or bone disease (except for metabolic bone disease in renal impairment (RI) subjects)
* History of osteoporosis, vertebral fracture, or fragility fracture of the wrist, humerus, hip, or pelvis after age 50
* Recent bone fracture
* Vitamin D insufficiency
* Hypocalcemia or hypercalcemia
* Hypomagnesemia
* Hypophosphatemia
* Untreated hyper- or hypothyroidism
* Females with a positive pregnancy test
* Males with pregnant partners
* Females who are lactating/breastfeeding or plan to breastfeed on study and for 3 months after receiving the dose of study drug
* History of spinal stenosis
* History of facial nerve paralysis
* Positive for human immunodeficiency virus (HIV) antibodies
* Positive for hepatitis B surface antigen or detectable hepatitis C
* Malignancy (except fully resected cutaneous basal cell or squamous cell carcinoma, cervical, or breast ductal carcinoma in situ) within 5 years before screening
* Current hyper- or hypoparathyroidism

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes