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

Amgen

Status and phase: Completed; Phase 1

Conditions: Osteoporosis

Treatments: Drug: Romosozumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01833754

20110227

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

INCLUSION CRITERIA - ALL SUBJECTS :

• 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

INCLUSION CRITERIA - SUBJECTS WITH RENAL IMPAIRMENT (GROUPS 1 AND 2):

• 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

INCLUSION CRITERIA - HEALTHY SUBJECTS (GROUP 3):

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

EXCLUSION CRITERIA - ALL SUBJECTS:

• 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
• History of solid organ or bone marrow transplants EXCLUSION CRITERIA - HEALTHY SUBJECTS (GROUP 3)
• Current hyper- or hypoparathyroidism

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

Group 1: Stage 4 Renal Impairment

Experimental group

Description:

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.

Treatment:

Drug: Romosozumab

Group 2: ESRD Requiring Hemodialysis

Experimental group

Description:

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

Treatment:

Drug: Romosozumab

Group 3: Healthy Participants

Experimental group

Description:

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

Treatment:

Drug: Romosozumab