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

Active, not recruiting

• Conditions: Advanced Breast Cancer

• Registration Number: NCT06338605
• Lead Sponsor: Erasmus Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-12
• Status Verified: 2024-03
• Study First Submitted: 2024-03-08
• Study First Submitted QC: 2024-03-28
• Last Update Submitted: 2024-03-28
• Study First Posted: 2024-03-29
• Last Update Posted: 2024-03-29
• Primary Completion: 2024-04-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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

Exclusion Criteria

• Patients who are undergoing dialysis therapy for kidney failure.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pseudo-AKI in patients on CDK4/6 inhibitors	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)

Secondary Outcome Measures

Name	Time	Method
Influencing factors cystatin C levels	jan-april 2024	The number of patients with influencing factors on cystatin C levels
Pseudo-AKI in patients on CDK4/6 inhibitors per drug	jan-april 2024	The percentage of patients (%) per CDK4/6 inhibitor with creatinin plasma levels indicating AKI
AKI in patients	jan-april 2024	The percentage of patients (%) on CDK4/6 inhibitors with cystatin C plasma levels indicating AKI

Trial Locations

Locations (1)

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands