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OpenTrials
Completed

NCT Number: NCT06119347

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

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.

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Key information

Conditions

AKI Incidence of Cancer Patients Receiving AntiVEGF or ICIs

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AntiVEGF

Drug

anti-vascular endothelial growth factor monoclonal antibody drug includes bevacizumab;

ICIs

Drug

immune checkpoint inhibitors include Pembrolizumab, Sintilimab, toripalimab, Camrelizumab, Tislelizumab.

Primary outcomes

  1. accumulative incidence of sustained AKI

    Time frame: 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

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Wenzhou Medical University

Other

Registry information

Official study title

Acute Kidney Injury in Cancer Patients Receiving Anti-Vascular Endothelial Growth Factor Monoclonal Antibody vs Immune Checkpoint Inhibitors: a Retrospective Real-world Study

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Nov 7, 2023
Registry last updated
Nov 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.