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Clinical Trials in Italy / NCT06728007
Recruiting Observational

Nephrological Outcome and Associated Congenital Anomalies in Pediatric Patients with Horseshoe Kidney

NCT06728007 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Phase
Observational
Started
2025-06-01
Last updated
2024-12-11

Condition(s) studied

Horseshoe Kidney

Study summary

A retrospective, observational multicentre trial on the nephrological outcome and associated congenital anomalies in children with Horseshoe Kidney.

Eligibility

Sex
ALL
Min age
—
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria: * Patients with confirmed ultrasound and/or scintigraphic diagnosis of horseshoe kidney; * Patients with an age at first assessment of between 0 and 18 years; * Obtaining written Informed consent. Exclusion Criteria: * Patients with a definitive diagnosis of another form of CAKUT during the diagnostic pathway.

Primary outcome measure(s)

  • Chronic kidney disease — at baseline
    Defined as a reduction in eGFR \<90ml/min/1.73m2, calculated using the Schwartz formula(18) corrected for age: * δ= 0.45 for children \<1 yr * δ= 0.55 for children of both sexes from 2 to 12 yrs and for female children aged 13 to 18 yrs * δ= 0.70 for children aged 13 to 18 yrs The different stages of chronic kidney have been further defined according to eGFR: * Stage I: \>90ml/min/1.73m2 * Stage II: between 89 and 60ml/min/1.73m2 * Stage III: between 59 and 30ml/min/1.73m2 * Stage IV: between 30 and 15ml/min/1.73m2 * Stadio V: lower than15ml/min/1.73m2 or patient in dialysis
  • Proteinuria — at baseline
    Defined as the urinary protein:creatinine ratio (mg/mg) \>0.5 in chilrden up to 2 yrs of age and \>0.2 in chilrden older than 2 yrs
  • Hypertension — at baseline
    Arterial blood pressure ≥95th percentile for sex, age and height, on at least three different readings

Trial sites (1)

FacilityCityRegionStatus
IRCCS Azienda Ospedaliero-Universitaria di Bologna Bologna Bologna Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06728007 on ClinicalTrials.gov ↗ ← All trials in Italy