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
• Trial end date: 2014-02-19
• Target enrollment: 0
• Participant gender: All

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 renal impairment (RI) or stage 5 RI requiring hemodialysis.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Amgen

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