A Multicenter Prospective Cohort Study to Establish a Predictive Model for the Treatment-Related Acute Kidney Disease by Noninvasive Tubular Aging Assessment

A Multicenter Prospective Cohort Study to Establish a Predictive Model for the Treatment-Related Acute Kidney Disease by Noninvasive Tubular Aging Assessment - A Multicenter Prospective Cohort Study to Establish a Predictive Model for the Treatment-Related Acute Kidney Disease by Noninvasive Tubular Aging Assessment

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000052433

Enrollment

400

Registered

2023-10-06

Start date

2023-10-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

acute kidney disease

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients undergoing anti-tumor chemotherapy

Exclusion criteria

Exclusion criteria: Under 16 years old

Design outcomes

Primary

Measure	Time frame
Onset of treatment-related AKD (failure of renal function recovery on day 7 or 30 after initiation of treatment: > 0.3 mg/dl or 1.5-fold increase in serum Cr compared to baseline)	—

Secondary

Measure	Time frame
1) Serum biomarker (soluble serum alpha Klotho) 2) Number of cells positive for P16 and P53 antibodies in urine cytology 3) Renal death and induction of dialysis (temporary or permanent) 4) Onset of AKI (>0.3 mg/dl increase in Cr value or >1.5-fold increase in Cr value or oliguria compared to baseline value within 2 days of starting treatment) and its stage 5) Development of CKD (decrease to eGFR <60 ml/min/1.73 m2 or positive urine protein: >1+ over 3 months of treatment) 6) Survival and treatment success rate (whether the planned treatment could be continued or not) 7) Age, gender, original disease, comorbidity (hypertension, diabetes, liver disease), concomitant medications, blood pressure, BMI 8) Details of treatment (dose and frequency of anti-tumor therapy, renal ischemia time, contrast medium dose, and volume of replacement fluid)	—

Measure

Time frame

1) Serum biomarker (soluble serum alpha Klotho) 2) Number of cells positive for P16 and P53 antibodies in urine cytology 3) Renal death and induction of dialysis (temporary or permanent) 4) Onset of AKI (>0.3 mg/dl increase in Cr value or >1.5-fold increase in Cr value or oliguria compared to baseline value within 2 days of starting treatment) and its stage 5) Development of CKD (decrease to eGFR <60 ml/min/1.73 m2 or positive urine protein: >1+ over 3 months of treatment) 6) Survival and treatment success rate (whether the planned treatment could be continued or not) 7) Age, gender, original disease, comorbidity (hypertension, diabetes, liver disease), concomitant medications, blood pressure, BMI 8) Details of treatment (dose and frequency of anti-tumor therapy, renal ischemia time, contrast medium dose, and volume of replacement fluid)

—

Countries

Japan

Contacts

Public ContactTadashi Sofue

Kagawa University Hospital Department of Nephrology

sofue.tadashi@kagawa-u.ac.jp087-891-2150

Outcome results