Acute Kidney Injury in Cancer Patients Receiving Anti-Vascular Endothelial Growth Factor Monoclonal Antibody vs Immune Checkpoint Inhibitors

Completed

• Conditions: AKI Incidence of Cancer Patients Receiving AntiVEGF or ICIs
• Interventions: Drug: ICIs; Drug: AntiVEGF

• Registration Number: NCT06119347
• Lead Sponsor: First Affiliated Hospital of Wenzhou Medical University

Brief Summary

The goal of this a retrospective real-world study is to compare the AKI events in cancer patients receiving anti-vascular endothelial growth factor monoclonal antibody (AntiVEGF) vs immune checkpoint inhibitors (ICIs). The main question it aims to answer is whether the choice between AntiVEGF and ICIs affects the risks of acute kidney injury in cancer patients.

Cancer patients receiving AntiVEGF will be compared to those treated with ICIs to see if the AKI incidence is higher in patients receiving ICIs.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2023-06-30
• Study Completion: 2023-10-10
• Study First Submitted: 2023-10-31
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-04
• Last Update Submitted: 2023-11-06
• Study First Posted: 2023-11-07
• Last Update Posted: 2023-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1581

Inclusion Criteria

• Age >=20yr;
• Patients must have at least one "Evaluation and Management"visit with a diagnosis of cancer within 12 months before index date (In situ biopsy will not be required, since patients may receive a diagnosis from a biopsy of metastatic site);
• Indication to initiate AntiVEGF or ICIs

Exclusion Criteria

• Patients without valid data and less than 3 months followup;
• Patients without baseline Scr value within 12 mon before index date;
• Patients with combination therapy of Anti-VEGF and ICIs ;
• Patients with chronic renal failure

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ICIs	ICIs	cancer patients receiving immune checkpoint inhibitors (ICIs).
AntiVEGF	AntiVEGF	cancer patients receiving anti-vascular endothelial growth factor monoclonal antibody (AntiVEGF)

Primary Outcome Measures

Name	Time	Method
accumulative incidence of sustained AKI	12 months after index date	sustained AKI will be defined as the elevation ≥1.5 times baseline sCr for ≥72hours according to the Kidney Disease Improving Global Outcomes (KDIGO) sCr criteria

Trial Locations

Locations (1)

The First Affiliated Hospital of Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China