ISRCTN39200026进行中（未招募）1 期
A multiple-center, non-randomized, open-label study to investigate the effect of various degrees of renal impairment on the pharmacokinetics of a single intravenous dose of RO7223280
F. Hoffmann-La Roche0 个研究点目标入组 70 人开始时间: 2023年4月19日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male and female participants aged 18 to 82 years of age inclusive at screening
- •2. Participants must have a body weight of at least 50 kg and a body mass index (BMI) within the range of 18 to 40 kg/m2 inclusive at screening and admission to the clinic
- •Criteria for participants with normal renal function only:
- •1. Participants must be in reasonably good health for their age group as determined by the Investigator
- •2. Estimated glomerular filtration rate (eGFR) at screening using the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) equation (based on serum creatinine) of =90 mL/min. The stability of renal function will be confirmed by 2 determinations of serum creatinine separated by at least 7 days. Renal function is considered stable if the two serum creatinine values differ by =20%
- •3. Matched to participants with mild, moderate, or severe renal impairment in sex, age (± 10 years), and BMI (± 15%) at screening
- •Criteria for participants with renal impairment only:
- •1. eGFR at screening and admission to the clinic using the CKD-EPI equation (based on serum creatinine) of: For mild renal impairment: =60 to <90 mL/min (Part 1); moderate renal impairment: =30 to <60 mL/min (Part 2); severe renal impairment: <30 mL/min (participants must not be on dialysis and in the opinion of the Investigator will not require dialysis during the study) (Part 3)
- •2. Stable renal function (Parts 1, 2, and 3). The stability of renal function will be confirmed by two determinations of serum creatinine separated by at least 7 days. Renal function is considered stable if the two serum creatinine values differ by =20%
- •Criteria for participants with ESRD requiring haemodialysis:
- •1. Reduced renal function with a clinical diagnosis of ESRD requiring renal replacement therapy
- •2. Requiring haemodialysis for more than 3 months at the time of the screening visit
排除标准
- •1. History or evidence of any medical conditions potentially altering the absorption, distribution, metabolism, or elimination of RO7223280, except those conditions associated with the primary renal disease
- •2. History of malignancy within the last year
- •3. Suffering from an active symptomatic infection (such as influenza, urinary tract infection, or gastrointestinal infections) within 2 weeks prior to treatment administration
- •4. Evidence of human immunodeficiency virus (HIV) infection and/or positive result for human HIV antibodies
- •5. Presence of hepatitis B surface antigen or positive hepatitis C antibody test result
- •6. History of hypersensitivity to any of the excipients in the formulation of RO7223280 or OmnipaqueTM
- •Criteria for participants with normal renal function only:
- •1. Significant history or clinical manifestation of renal disorder, as determined by the Investigator
- •2. History or presence of renal disease or renal injury as indicated by any clinically significant deviations from normal reference ranges in renal function tests, unless approved by the Investigator
- •Criteria for participants with renal impairment or ESRD requiring haemodialysis only:
- •1. Nephrotic syndrome (defined as plasma albumin <2 g/dL combined with proteinuria >3 g/day)
- •2. Participants with renal impairment due to hepatic disease (hepatorenal syndrome)
- •3. Presence of a renal carcinoma, or an acute renal disease caused by infection or drug toxicity
- •4. Subjects with a functioning renal transplant or who are active on the transplant waiting list
- •5. Values outside the normal range for renal and liver function tests that are not consistent with their renal condition, as determined by the Investigator.
- •6. Blood potassium concentration <3 mmol/L or > 6.5 mmol/L at screening or admission to the clinic
- •7. Hyponatremia (<120 mmol/L) or hypernatremia (>150 mmol/L) at screening or admission to the clinic
- •8. Clinically significant liver disease, e.g., hepatitis, cirrhosis, and/or confirmed liver enzymes
- •9. Haemoglobin concentration <8.5 g/dL at screening or admission to the clinic
研究者
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