一个阶段3b,多中心,开放标签,单臂研究roxadustat (ASPEN):在美国透析组织的操作学习
Steven Fishbane1, Mark Vishnepolsky2, Yemmie Oluwatosin3
1Department of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Great Neck, New York, USA.
Hemodialysis international. International Symposium on Home Hemodialysis
|June 28, 2023
概括
在接受透析的慢性病 (CKD) 贫血患者中,罗沙沙斯塔特有效地维持了血红蛋白水平. 这项在美国透析机构进行的研究表明,口服治疗的有效性和安全性结果是积极的.
科学领域:
- 腎臟病學 (nephrology) 是一種醫學.
- 血液学 血液学 血液学
- 药理学 药理学是指药理学的学科.
背景情况:
- 贫血是慢性病 (CKD) 患者的常见并发症.
- 罗克萨杜沙特是一种口服缺氧诱导因子酸酶抑制剂,已获批准用于治疗各种地区的慢性病贫血.
- 在ASPEN研究中评估了roxadustat在美国透析环境中的有效性和安全性.
研究的目的:
- 评估在接受透析的CKD患者中治疗贫血的口服roxadustat的疗效,安全性和可行性.
- 评估roxadustat在一个大规模的社区透析人群中维持血红蛋白水平的能力.
主要方法:
- 一项开放式单臂研究 (NCT04484857) 涉及283名慢性透析患者.
- 患者在24周内每周服用三次口服罗沙杜沙特,可选延长时间.
- 主要终点包括患者达到平均血红蛋白 (Hb) ≥10 g/dL的比例和平均Hb变化.
主要成果:
- 83.7%的患者在16-24周之间达到平均Hb≥10g/dL.
- 平均Hb比基线增加为0.2g/dL.
- 治疗引起的严重不良事件发生在29.0%的患者中,COVID-19肺炎和急性呼吸衰竭是最常见的.
结论:
- 罗沙杜沙特在透析中患有CKD贫血的患者的血红蛋白水平维持方面表现出有效性.
- 这项研究支持roxadustat在美国大型社区透析组织中的可行性和有效性.
相关概念视频
01:28Chronic Kidney Disease III: Interprofessional Care
48
Chronic kidney disease (CKD) requires collaborative and comprehensive management. CKD progresses through stages and can lead to end-stage kidney disease (ESKD) if untreated. Interprofessional collaboration and patient education are crucial, enabling patients to manage their health and improve their quality of life.Diagnostic approach for chronic kidney diseaseThe diagnosis of CKD primarily focuses on the glomerular filtration rate (GFR), which assesses kidney function by measuring how well...
48
01:15Renal Drug Excretion: Overview
189
As primary excretory organs, the kidneys maintain homeostasis by removing waste substances from the bloodstream. They comprise over a million units called nephrons, which serve as the kidney's functional units.
A nephron consists of two primary structures: the renal corpuscle and the renal tubule. The renal corpuscle contains the glomerulus, a network of capillaries where the first step of renal excretion, glomerular filtration, occurs. Blood pressure forces water, ions, and small molecules...
A nephron consists of two primary structures: the renal corpuscle and the renal tubule. The renal corpuscle contains the glomerulus, a network of capillaries where the first step of renal excretion, glomerular filtration, occurs. Blood pressure forces water, ions, and small molecules...
189
01:06Renal Drug Clearance: Overview
255
Renal clearance is a crucial parameter in pharmacokinetics that quantifies the rate at which the kidneys excrete a drug. It represents a constant fraction of the central volume of distribution containing the drug that the kidney eliminates per unit of time.
Renal clearance can be calculated using different methods. One approach is to divide the urinary drug excretion rate by the plasma drug concentration. This method directly measures renal clearance, indicating the kidneys' efficiency in...
Renal clearance can be calculated using different methods. One approach is to divide the urinary drug excretion rate by the plasma drug concentration. This method directly measures renal clearance, indicating the kidneys' efficiency in...
255
01:25Renal Drug Excretion: Tubular Reabsorption
227
Tubular reabsorption, a process occurring post-glomerular filtration of drugs in the renal tubule, is a critical determinant of drug half-life. During the process of renal excretion, as the glomerular filtrate progresses to the distal convoluted tubule (DCT), drugs that are highly permeable, lipophilic, and nonionized undergo passive reabsorption from the tubular fluid into the surrounding peritubular capillaries. This reabsorption process restricts their elimination through the kidneys. This...
227
01:11Renal Failure: Dose Adjustments
127
In patients with renal impairment, drugs undergo significant changes in their pharmacokinetics, which require dosage adjustments to ensure safe and effective therapy.
Reduced renal clearance and elimination rate are common outcomes of renal impairment. These alterations lead to a prolonged elimination half-life and an altered apparent volume of distribution for drugs. As a result, dosage adjustments are typically necessary to maintain optimal drug levels in the body.
However, dosage adjustments...
Reduced renal clearance and elimination rate are common outcomes of renal impairment. These alterations lead to a prolonged elimination half-life and an altered apparent volume of distribution for drugs. As a result, dosage adjustments are typically necessary to maintain optimal drug levels in the body.
However, dosage adjustments...
127
01:25Hemodialysis III: Nursing Management
50
The nursing management of a patient undergoing hemodialysis includes several critical steps, starting with a thorough assessment before the procedure.Before the Hemodialysis ProcedureFirst, record the patient's vital signs—blood pressure, heart rate, respiratory rate, and temperature—to establish a baseline. This baseline is essential for detecting conditions such as hypotension that could impact the patient's response to dialysis. Document the patient's pre-dialysis weight, as this...
50