Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06338605
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-29
First Post:
2024-03-08
Brief Title:
Evaluating the Incidence of Pseudo-Acute Kidney Injuries in Patients With Metastatic Breast Cancer on CDK46 Inhibitors Trough Cystatin C Analysis
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
Evaluating the Incidence of Pseudo-Acute Kidney Injuries in Patients With Metastatic Breast Cancer on CDK46 Inhibitors Trough Cystatin C Analysis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CYSTATINcDK46
Brief Summary:
CDK46 inhibitors have led to an improvement of both progression free survival PFS and overall survival OS in patients with advanced estrogen positive ERHER2- breast cancer when applied in the first or second line of treatment Despite the advantages of CDK46 inhibitors these medications can lead to adverse effects One of the adverse events observed across all types of CDK46 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 CDK46 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 CDK46 inhibitor treatment by assessing both creatinine and cystatin C in plasma
The incidence of pseudo-AKI in patients using CDK46 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 CDK46 inhibitor treatment by assessing both creatinine and cystatin C in plasma
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None