Study of Romosozumab (AMG 785) Administered to Healthy Participants and Patients With Stage 4 Renal Impairment or Stage 5 Renal Impairment Requiring Hemodialysis
- Registration Number
- NCT01833754
- Lead Sponsor
- Amgen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1: Stage 4 Renal Impairment Romosozumab 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. Group 2: ESRD Requiring Hemodialysis Romosozumab Participants with end stage renal disease (ESRD) requiring hemodialysis received a single subcutaneous injection of 210 mg romosozumab on day 1. Group 3: Healthy Participants Romosozumab Healthy participants (eGFR ≥ 80 mL/min/1.73 m²) received a single subcutaneous injection of 210 mg romosozumab on day 1.
- Primary Outcome Measures
Name Time Method Number of Participants Who Developed Anti-Romosozumab Antibodies Baseline and day 85 Two validated assays were used to detect the presence of anti-romosozumab antibodies. First, an electrochemiluminescent immunoassay was used to detect binding antibodies (screening assay) and confirm antibodies (confirmatory assay) capable of binding romosozumab. Second, a non-cell-based competitive binding bioassay was used to test positive binding antibody samples for neutralizing activity against romosozumab.
If a sample was positive for binding antibodies and demonstrated neutralizing activity at the same time point, the participant was defined as positive for neutralizing antibodies.Albumin-Adjusted Serum Calcium Concentrations by Visit Baseline, days 8, 15, 22, 29, 43, 57, and 85/end of study visit Albumin-adjusted calcium was derived as:
Where serum albumin \< 40 g/L then albumin-adjusted calcium = measured total calcium (mmol/L) + 0.02 \* \[40 - serum albumin (g/L)\]; Where serum albumin ≥ 40 g/L then albumin-adjusted calcium = measured total calcium.Intact Parathyroid Hormone (iPTH)Concentrations by Visit Baseline, days 8, 15, 22, 29, 43, 57, and 85/end of study visit Number of Participants With Adverse Events From the first dose of study drug up to day 85 A serious adverse event was defined as an adverse event (AE) that met at least 1 of the following serious criteria:
* fatal
* life-threatening
* required in-patient hospitalization or prolongation of existing hospitalization
* resulted in persistent or significant disability/incapacity
* congenital anomaly/birth defect
* other medically important serious event. A treatment-related adverse event (TRAE) was an AE assessed by the investigator as possibly related to the study drug, indicated by a "yes" response to the question: "Is there a reasonable possibility that the event may have been caused by the investigational product?"
- Secondary Outcome Measures
Name Time Method Time to Maximum Observed Serum Concentration (Tmax) of Romosozumab Pre-dose on day -1 and on days 2, 3, 4, 6, 8, 11, 15, 18, 22, 29, 36, 43, 57 and 85 Area Under the Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) Pre-dose on day -1 and on days 2, 3, 4, 6, 8, 11, 15, 18, 22, 29, 36, 43, 57 and 85 Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) Pre-dose on day -1 and on days 2, 3, 4, 6, 8, 11, 15, 18, 22, 29, 36, 43, 57 and 85 Maximum Observed Serum Concentration (Cmax) of Romosozumab Pre-dose on day -1 and on days 2, 3, 4, 6, 8, 11, 15, 18, 22, 29, 36, 43, 57 and 85
Trial Locations
- Locations (1)
Research Site
🇺🇸Orangeburg, South Carolina, United States