Study of Romosozumab (AMG 785) Administered to Healthy Participants and Patients With Stage 4 Renal Impairment or Stage 5 Renal Impairment Requiring Hemodialysis
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Keep this study
Lead
Amgen
Age
50–any
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Study of Romosozumab (AMG 785) Administered to Healthy Participants and Patients With Stage 4 Renal Impairment or Stage 5 Renal Impairment Requiring Hemodialysis
