Novel Biomarkers and Postoperative Kidney Injury in Radical Nephrectomy

August 31, 2025 updated by: Qiongfang Wu, Peking University First Hospital

Novel Biomarkers to Predict Acute Kidney Injury and Chronic Kidney Disease After Radical Nephrectomy: an Exploratory Prospective Cohort Study

The incidence of acute kidney injury (AKI) after radical nephrectomy exceeds 40%. Currently, the KDIGO criteria are the recognized diagnostic standard for AKI. These criteria primarily use serum creatinine and urine output as key indicators, but both parameters have certain limitations, such as delayed response, insensitivity, and inaccuracy. This study aims to simultaneously monitor perioperative novel renal damaging, stressful, and functional biomarkers in patients undergoing radical nephrectomy, and to investigate their predictive value for AKI and postoperative 1-year chronic kidney disease (CKD).

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

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

Study Contact

  • Name: Qiongfang Wu, MD
  • Phone Number: 8610 83572460
  • Email: wuqf91@163.com

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100034
        • Recruiting
        • Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital
        • Contact:
        • Contact:

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

Targeting patients undergoing radical nephrectomy for renal cell carcinoma

Description

Inclusion Criteria:

  • Age ≥18 years;
  • Scheduled to undergo unilateral radical nephrectomy.

Exclusion Criteria:

  • Solitary kidney;
  • Preoperative diagnosis of chronic kidney disease stages G4 or G5 (GFR <30 mL/min/1.73m²);
  • Tumor invasion of the vena cava requiring thrombectomy;
  • Other conditions deemed by the investigator as unsuitable for participation in this study.

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
AKI group/CKD group
  1. patients diagnosed with AKI after radical nephrectomy.
  2. patients diagnosed with the new onset/worsening of CKD after radical nephrectomy.
non-AKI group/non-CKD group
  1. patients without AKI after radical nephrectomy.
  2. patients without new onset/worsening of CKD after radical nephrectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The urinary [TIMP-2]×[IGFBP-7], urinary NGAL, urinary KIM-1, serum cystatin C and their combinations to predict postoperative AKI occurring within 7 days.
Time Frame: Up to 7 days after surgery.
Novel biomarkers above were collected at the end of surgery, and at postoperative 1h, 6h, and 20h. AKI diagnosed according to 2012 KDIGO criteria (occurring within 7 days after surgery).
Up to 7 days after surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The urinary [TIMP-2]×[IGFBP-7], urinary NGAL, urinary KIM-1, serum cystatin C and their combinations to predict new onset/worsening CKD occurring within 1 year after surgery.
Time Frame: Up to 1 year after surgery
Novel biomarkers above were collected before and at the end of surgery, and at postoperative 1h, 6h, and 20h. CKD diagnosed according to 2024 KDIGO-CKD criteria (occurring within 1 year after surgery).
Up to 1 year after surgery
The urinary [TIMP-2]×[IGFBP-7], urinary NGAL, urinary KIM-1, serum cystatin C combined with clinically important risk factors to predict postoperative AKI occurring within 7 days after surgery.
Time Frame: Up to 7 days after surgery.
Novel biomarkers above were collected before and at the end of surgery, and at postoperative 1h, 6h, and 20h. AKI diagnosed according to 2012 KDIGO criteria (occurring within 7 days after surgery).
Up to 7 days after surgery.
The postoperative urinary [TIMP-2]×[IGFBP-7], urinary NGAL, urinary KIM-1, serum cystatin C combined with clinically important risk factors to predict postoperative the new onset/worsening CKD occurring within 1 year after surgery.
Time Frame: Up to 1 year after surgery.
Novel biomarkers above were collected before and at the end of surgery, and at postoperative 1h, 6h, and 20h. CKD diagnosed according to 2024 KDIGO-CKD criteria (occurring within 1 year after surgery).
Up to 1 year after surgery.

Collaborators and Investigators

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

Sponsor

Peking University First Hospital

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)

August 2, 2025

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

July 30, 2027

Study Registration Dates

First Submitted

July 10, 2025

First Submitted That Met QC Criteria

July 25, 2025

First Posted (Actual)

July 28, 2025

Study Record Updates

Last Update Posted (Estimated)

September 8, 2025

Last Update Submitted That Met QC Criteria

August 31, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-067

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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