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

NCT06728007 | Recruiting

• 1 other identifier: HSK-PED-23-01
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Horseshoe Kidney

Keywords

Horseshoe Kidney; Congenital anomalies; Children; CAKUT

Outcome Measures

Primary Outcomes (3)

• Chronic kidney disease

  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

  at baseline

• Proteinuria

  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

  at baseline

• Hypertension

  Arterial blood pressure ≥95th percentile for sex, age and height, on at least three different readings

  at baseline

Secondary Outcomes (6)

• Urinary tract infections

  at baseline

• Nephrolithiasis

  at baseline

• Renal neoplasms

  at baseline

• Renal anatomical features

  at baseline

• Renal anatomical features

  at baseline

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients followed at the participating centres from 01/01/2012 to 31/12/2021 for a nephro-urological pathology will be enrolled in the study.

You may qualify if:

• 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.

You may not qualify if:

• Patients with a definitive diagnosis of another form of CAKUT during the diagnostic pathway.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Fused Kidney; Congenital Abnormalities; Cakut

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Claudio La Scola, MD, PhD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudio La Scola, MD, PhD

CONTACT

00390512144650; claudio.lascola@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 11, 2024
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 11, 2024

Record last verified: 2024-11

Locations

IT (1)