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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01833754
First received: April 15, 2013
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

This is an open-label, single-dose, parallel-group study conducted in healthy subjects and subjects with stage 4 renal impairment (RI) or end stage renal disease (ESRD) requiring hemodialysis to evaluate the safety, tolerability, and immunogenicity profile of romosozumab. Subjects will enroll in parallel into 1 of three treatment groups to receive a single dose of romosozumab.


Condition Intervention Phase
Osteoporosis
Drug: Romosozumab
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Romosozumab PK parameters [ Time Frame: 15 timepoints, 85 days ] [ Designated as safety issue: No ]
    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


Enrollment: 24
Study Start Date: April 2013
Study Completion Date: April 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Stage 4 renal impairment (estimated glomerular filtration rate (eGFR)] 15 to 29 mL/min/1.73 m2)
Drug: Romosozumab
Subcutaneous, Single Dose, Single Dose Level
Other Name: AMG 785
Experimental: Group 2
End stage renal disease requiring hemodialysis
Drug: Romosozumab
Subcutaneous, Single Dose, Single Dose Level
Other Name: AMG 785
Experimental: Group 3
Healthy subjects (estimated glomerular filtration rate (eGFR) ≥ 80 mL/min/1.73 m2)
Drug: Romosozumab
Subcutaneous, Single Dose, Single Dose Level
Other Name: AMG 785

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01833754     History of Changes
Other Study ID Numbers: 20110227
Study First Received: April 15, 2013
Last Updated: April 14, 2014
Health Authority: United States: Food and Drug Administration

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
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 22, 2014