一个美国透析组织中的roxadustat的3b期,多中心,开放标签,单臂研究:DENALI研究
John Larkin1, Jeffrey Hymes1, Marcus L Britton2
1Fresenius Medical Care, Global Medical Office, Waltham, Massachusetts, USA.
Hemodialysis international. International Symposium on Home Hemodialysis
|October 24, 2023
概括
在透析患者中,Roxadustat有效地通过维持血红蛋白水平来治疗贫血. 在DENALI研究中,口服药物表现出很高的坚持性和没有新的安全问题.
科学领域:
- 腎臟病學 (nephrology) 是一種醫學專業.
- 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.
- 口服的低氧诱导因子酸酶抑制剂,如roxadustat,提供了一种新的治疗方法.
- 在DENALI研究中,在接受透析的慢性脏病贫血患者中评估了roxadustat.
研究的目的:
- 评估roxadustat在达到和维持目标血红蛋白水平方面的疗效.
- 评估roxadustat在这个患者群体中的安全性.
- 确定将口服罗克萨斯达特纳入透析机构的可行性.
主要方法:
- 一项3b期的开放性研究,涉及203名透析中慢性病贫血患者.
- 罗沙沙斯塔特在24周内每周服用三次口服.
- 疗效终点包括患者达到平均血红蛋白 (Hb) ≥10.0 g/dL的比例和平均Hb变化.
主要成果:
- 84.6%的患者实现了平均Hb≥10.0g/dL,平均在16-24周.
- 与基线的平均Hb变化为0.5g/dL.
- 剂量遵守率高达94%,没有发现新的安全信号.
结论:
- 在透析中患有慢性瘤贫血的患者中,Roxadustat有效地达到和维持血红蛋白目标水平.
- 在透析机构内,口服roxadustat的使用是可行的.
- 在被研究的人群中,Roxadustat表现出良好的安全性.
相关概念视频
01:28Chronic Kidney Disease III: Interprofessional Care
21
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...
21
01:15Renal Drug Excretion: Overview
166
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...
166
01:06Renal Drug Clearance: Overview
224
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...
224
01:25Renal Drug Excretion: Tubular Reabsorption
193
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...
193
01:11Renal Failure: Dose Adjustments
97
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...
97
01:28Renal Drug Excretion: Tubular Secretion
196
Active tubular secretion is a robust, energy-demanding process that utilizes carrier systems to transport drugs into renal tubules. The active renal secretion systems include the organic anion transporter (OAT) for weak acids and the organic cation transporter (OCT) for weak bases. Structurally similar drugs can compete for the same transporter, potentially leading to drug accumulation and toxicity. However, this principle can be exploited therapeutically. One example is probenecid (Probalan),...
196