Effect of PARP Inhibitors on Glomerular Filtration Rate
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Change in eGFR from Baseline to On-Treatment, 3-9 weeks after PARPi Initiation (Time Point B)
研究概览
简要总结
The purpose of this study is to observe whether PARP inhibitors have an effect on serum creatinine level, and whether this reflects a change in creatinine secretion or a true change in kidney function.
详细描述
PARPi medications interact with transporters along the renal tubules involved in the secretion of creatinine and an increase in serum creatinine is often observed in patients treated with these agents; however, it is not known whether PARP inhibitors are associated with an actual change in the glomerular filtration rate, or if the observed elevations of serum creatinine are a result of a drug effect on creatinine secretion unrelated to changes in kidney function. The investigators therefore propose a prospective observational study to examine the incidence of elevation in serum creatinine from baseline levels in patients initiated on PARP inhibitors and compare the estimated glomerular filtration rate based on creatinine to that from alternative tests.
The primary purposes of this study are to:
- Assess the incidence of increase in serum creatinine in patients with a solid-organ cancer on treatment with a PARP inhibitor.
- To compare the estimated glomerular filtration rate based on serum creatinine with that of alternative biomarkers to assess whether changes in serum creatinine reflect changes in kidney function or creatinine secretion.
- To examine the persistence or resolution of creatinine increase and/or GFR decrease noted after discontinuation of PARPi
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients age 18 years or older
- •Diagnosed with any solid organ cancer
- •Planned to receive a PARP inhibitor (olaparib, niraparib, rucaparib, veliparib, or talazoparib)
- •Able to consent to study related procedures
- •If unable to give informed consent, must have healthcare proxy or legally authorized representative
- •Fluent in conversational English (Informed Consent form currently in English language)
排除标准
- •Patients who will not receive ongoing cancer care at Penn Medicine
- •Major psychiatric illness or cognitive impairment that in the judgment of the study investigators or study staff would preclude study participation
- •Any patients who are unable to comply with the study procedures as determined by the study investigators or study staff
- •Patients on dialysis
结局指标
主要结局
Change in eGFR from Baseline to On-Treatment, 3-9 weeks after PARPi Initiation (Time Point B)
时间窗: Study labs will be obtained within 3-9 weeks after PARPi is initiated
Change in eGFR from baselineto on-treatment by ≥20% as measured using either cystatin C or 24h urine collection
次要结局
- Within 4 Weeks of Post-discontinuation of PARPi (Time Point C) for patients with clinically significant changes in eGFR based on serum creatinine, cystatin C, or 24 hour urinalysis at Timepoint B(Post-treatment (within 4 weeks of PARP inhibitor discontinuation, only for those patients with clinically significant changes in GFR based on serum creatinine, cystatin C, or 24 hour urinalysis at Timepoint B)