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临床试验/NCT06338605
NCT06338605进行中(未招募)不适用

Evaluating the Incidence of Pseudo-Acute Kidney Injuries in Patients With Metastatic Breast Cancer on CDK4/6 Inhibitors Trough Cystatin C Analysis

Erasmus Medical Center1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年12月12日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40
试验地点
1
主要终点
Pseudo-AKI in patients on CDK4/6 inhibitors

研究概览

简要总结

CDK4/6 inhibitors have led to an improvement of both progression free survival (PFS) and overall survival (OS) in patients with advanced estrogen positive (ER+)/HER2- breast cancer when applied in the first or second line of treatment. Despite the advantages of CDK4/6 inhibitors, these medications can lead to adverse effects. One of the adverse events observed across all types of CDK4/6 inhibitors is an elevation in creatinine levels. An elevation in plasma creatinine during treatment with abemaciclib is not always indicative of a reduction in renal function; it can also be attributed to the inhibition of active tubular secretion of creatinine. This phenomenon is known as pseudo acute kidney injury (pseudo-AKI).

The incidence of pseudo-AKI in patients using CDK4/6 inhibitors is currently unknown. A method to distinguish pseudo-AKI from AKI is measuring the level of an alternative filtration marker in blood, for example cystatin C. Cystatin C is also filtered at the glomerulus but not secreted intro the renal tubulus or reabsorbed into the bloodstream. Also, there is no affection by muscle mass or diet. In this study the investigators will explore the incidence of both AKI and pseudo-AKI in patients who are treated with CDK4/6 inhibitor treatment by assessing both creatinine and cystatin C in plasma.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients who are receiving CDK4/6 inhibitors for metastatic breast cancer
  • Patients must have used the CDK4/6 inhibitor for a minimum duration of one month
  • Patients must have undergone at least one measurement of creatinine after the initiation of CDK4/6 inhibitor treatment

排除标准

  • Patients who are undergoing dialysis therapy for kidney failure.

结局指标

主要结局

Pseudo-AKI in patients on CDK4/6 inhibitors

时间窗: jan-april 2024

Percentage of patients with pseudo-AKI (%), i.e. patients with creatinin plasma levels (mmol/L) indicating AKI, but normal cystatin C levels (mg/mL)

次要结局

  • Influencing factors cystatin C levels(jan-april 2024)
  • Pseudo-AKI in patients on CDK4/6 inhibitors per drug(jan-april 2024)
  • AKI in patients(jan-april 2024)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Agnes Jager MD, PhD

Principal Investigator

Erasmus Medical Center

研究点 (1)

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