Status:
COMPLETED
Study of Romosozumab (AMG 785) Administered to Healthy Participants and Patients With Stage 4 Renal Impairment or Stage 5 Renal Impairment Requiring Hemodialysis
Lead Sponsor:
Amgen
Conditions:
Osteoporosis
Eligibility:
All Genders
50+ years
Phase:
PHASE1
Brief Summary
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 r...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 22 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 19 2014
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01833754
Start Date
April 22 2013
End Date
February 19 2014
Last Update
July 22 2022
Active Locations (5)
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1
Research Site
Tempe, Arizona, United States, 85284
2
Research Site
Los Angeles, California, United States, 90022
3
Research Site
Denver, Colorado, United States, 80230
4
Research Site
Pembroke Pines, Florida, United States, 33028