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

November 6, 2023 updated by: Tianxin Chen, First Affiliated Hospital of Wenzhou Medical University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1581

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325000
        • The First Affiliated Hospital of Wenzhou Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

patients with malignancies treated with AntiVEGF or ICIs between Jan 2020 and December 2022

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AntiVEGF
cancer patients receiving anti-vascular endothelial growth factor monoclonal antibody (AntiVEGF)
Drug: AntiVEGF
anti-vascular endothelial growth factor monoclonal antibody drug includes bevacizumab;
ICIs
cancer patients receiving immune checkpoint inhibitors (ICIs).
Drug: ICIs
immune checkpoint inhibitors include Pembrolizumab, Sintilimab, toripalimab, Camrelizumab, Tislelizumab.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months after index date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Wenzhou Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

October 10, 2023

Study Registration Dates

First Submitted

October 31, 2023

First Submitted That Met QC Criteria

November 4, 2023

First Posted (Actual)

November 7, 2023

Study Record Updates

Last Update Posted (Estimated)

November 8, 2023

Last Update Submitted That Met QC Criteria

November 6, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2023-R206

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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