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NCT Number: NCT07088874

Novel Biomarkers and Postoperative Kidney Injury in Radical Nephrectomy

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).

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Key information

Conditions

Nephrectomy Acute Kidney Injury Biomarker Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Qiongfang Wu, MD

CONTACT

[email protected]

8610 83572460

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jul 28, 2025
Registry last updated
Sep 8, 2025

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.

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