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Study of Romosozumab (AMG 785) Administered to Healthy Participants and Patients With Stage 4 Renal Impairment or Stage 5 Renal Impairment Requiring Hemodialysis

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ClinicalTrials.gov Identifier: NCT01833754
Recruitment Status : Completed
First Posted : April 17, 2013
Last Update Posted : June 8, 2017
Sponsor:
Information provided by (Responsible Party):
Amgen

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

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: Romosozumab Phase 1

Study Design
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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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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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:
  • AMG 785
  • EVENITY™
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:
  • AMG 785
  • EVENITY™
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:
  • AMG 785
  • EVENITY™


Outcome Measures
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Primary Outcome Measures :
  1. • 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 ]

Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
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
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site

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