Phase 1
Completed N=24
Study of Romosozumab (AMG 785) Administered to Healthy Participants and Patients With Stage 4 Renal Impairment or Stage 5 Renal Impairment Requiring Hemodialysis
Source: ClinicalTrials.gov NCT01833754 ↗Enrolled (actual)
24
Serious AEs
8.3%
Results posted
Feb 2019
Primary outcomePrimary: Number of Participants With Adverse Events — 7; 6; 0; 1 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
7; 6; 0; 1; 1; 0 | — |
| PRIMARY Number of Participants Who Developed Anti-Romosozumab Antibodies |
0; 0; 1; 0; 0; 0 | — |
| PRIMARY Albumin-Adjusted Serum Calcium Concentrations by Visit |
2.452; 2.379; 2.340; 2.355; 2.226; 2.308 | — |
| PRIMARY Intact Parathyroid Hormone (iPTH)Concentrations by Visit |
5.014; 11.765; 4.682; 9.192; 19.812; 6.776 | — |
| SECONDARY Maximum Observed Serum Concentration (Cmax) of Romosozumab |
28.9; 19.8; 22.4 | — |
| SECONDARY Time to Maximum Observed Serum Concentration (Tmax) of Romosozumab |
5.0; 5.0; 5.0 | — |
| SECONDARY Area Under the Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) |
637; 444; 443 | — |
| SECONDARY Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) |
642; 447; 445 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01833754). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.