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

Advanced Breast Cancer Clinical Trial

— CYSTATINcDK4/6  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06338605
• Other study ID #: MEC-2023-0715
• Status: Active, not recruiting
• Start date: December 12, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: March 2024
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: June 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Advanced Breast Cancer
• Breast Neoplasms

Intervention

Other:
• no intervention, observational study of AKI under CDK4/6 inhibitor treatment
no intervention

Locations

Country	Name	City	State
Netherlands	Erasmus Medical Center	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pseudo-AKI in patients on CDK4/6 inhibitors	Percentage of patients with pseudo-AKI (%), i.e. patients with creatinin plasma levels (mmol/L) indicating AKI, but normal cystatin C levels (mg/mL)	jan-april 2024
Secondary	Pseudo-AKI in patients on CDK4/6 inhibitors per drug	The percentage of patients (%) per CDK4/6 inhibitor with creatinin plasma levels indicating AKI	jan-april 2024
Secondary	AKI in patients	The percentage of patients (%) on CDK4/6 inhibitors with cystatin C plasma levels indicating AKI	jan-april 2024
Secondary	Influencing factors cystatin C levels	The number of patients with influencing factors on cystatin C levels	jan-april 2024