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Novel Biomarkers and Postoperative Kidney Injury in Radical Nephrectomy

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07088874
Enrollment
60
Registered
2025-07-28
Start date
2025-08-02
Completion date
2027-07-30
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury, Biomarker, Nephrectomy

Brief summary

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).

Interventions

None listed

Sponsors

Peking University First Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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.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

MeasureTime frameDescription
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.Up to 1 year after surgeryNovel 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).
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.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).
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.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).

Countries

China

Contacts

Primary ContactQiongfang Wu, MD
wuqf91@163.com8610 83572460

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026