Study of Romosozumab (AMG 785) Administered to Healthy Participants and Patients With Stage 4 Renal Impairment or Stage 5 Renal Impairment Requiring Hemodialysis
Status: | Completed |
---|---|
Conditions: | Osteoporosis, Renal Impairment / Chronic Kidney Disease |
Therapuetic Areas: | Nephrology / Urology, Rheumatology |
Healthy: | No |
Age Range: | 50 - Any |
Updated: | 2/27/2019 |
Start Date: | April 22, 2013 |
End Date: | February 19, 2014 |
A Phase 1, Open-label, Single-dose Study of Romosozumab (AMG 785) Administered Subcutaneously to Healthy Subjects and Subjects With Stage 4 Renal Impairment or Stage 5 Renal Impairment Requiring Hemodialysis
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.
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.
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
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