Study of Romosozumab (AMG 785) Administered to Healthy Participants and Patients With Stage 4 Renal Impairment or Stage 5 Renal Impairment Requiring Hemodialysis
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01833754 |
Recruitment Status
:
Completed
First Posted
: April 17, 2013
Last Update Posted
: June 8, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Osteoporosis | Drug: Romosozumab | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | April 22, 2013 |
Actual Primary Completion Date : | February 19, 2014 |
Actual Study Completion Date : | February 19, 2014 |
Arm | Intervention/treatment |
---|---|
Experimental: Group 1: Stage 4 Renal Impairment
Participants with stage 4 renal impairment (defined as an estimated glomerular filtration rate [eGFR] 15 to 29 mL/min/1.73 m²) received a single subcutaneous injection of 210 mg romosozumab on day 1.
|
Drug: Romosozumab
Administered as three 70 mg/mL prefilled syringe injections
Other Names:
|
Experimental: Group 2: ESRD Requiring Hemodialysis
Participants with end stage renal disease (ESRD) requiring hemodialysis received a single subcutaneous injection of 210 mg romosozumab on day 1.
|
Drug: Romosozumab
Administered as three 70 mg/mL prefilled syringe injections
Other Names:
|
Experimental: Group 3: Healthy Participants
Healthy participants (eGFR ≥ 80 mL/min/1.73 m²) received a single subcutaneous injection of 210 mg romosozumab on day 1.
|
Drug: Romosozumab
Administered as three 70 mg/mL prefilled syringe injections
Other Names:
|
- • Subject incidence of treatment-emergent adverse events • Results of safety laboratory tests, vital sign measurements, and ECG measurements • Subject incidence of anti-romosozumab antibodies [ Time Frame: 85 days ]
- Romosozumab PK parameters [ Time Frame: 15 timepoints, 85 days ]Romosozumab serum PK parameters (ie, area under the curve [AUClast, AUCinf], maximum observed concentration [Cmax], and time to reach maximum observed concentration [tmax]): Concentration-time profiles for romosozumab

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 50 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01833754
United States, Arizona | |
Research Site | |
Tempe, Arizona, United States, 85284 | |
United States, California | |
Research Site | |
Los Angeles, California, United States, 90022 | |
United States, Colorado | |
Research Site | |
Denver, Colorado, United States, 80230 | |
United States, Florida | |
Research Site | |
Pembroke Pines, Florida, United States, 33028 | |
United States, South Carolina | |
Research Site | |
Orangeburg, South Carolina, United States, 29118 |
Study Director: | MD | Amgen |
Additional Information:
Responsible Party: | Amgen |
ClinicalTrials.gov Identifier: | NCT01833754 History of Changes |
Other Study ID Numbers: |
20110227 |
First Posted: | April 17, 2013 Key Record Dates |
Last Update Posted: | June 8, 2017 |
Last Verified: | June 2017 |
Keywords provided by Amgen:
Osteoporosis, Bone, Renal, Insufficiency, Kidney, Hemodialysis, Impairment |
Additional relevant MeSH terms:
Osteoporosis Renal Insufficiency Bone Diseases, Metabolic Bone Diseases |
Musculoskeletal Diseases Metabolic Diseases Kidney Diseases Urologic Diseases |