Nephrological Outcome and Associated Congenital Anomalies in Pediatric Patients with Horseshoe Kidney
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Horseshoe Kidney. Basic parameters: up to 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
A retrospective, observational multicentre trial on the nephrological outcome and associated congenital anomalies in children with Horseshoe Kidney.
Detailed description
Congenital abnormalities of the kidney and urinary tract (CAKUT) represent the main cause of CKD in children. Among them, the horseshoe kidney (HSK) represents one of the most frequent and is characterised by the presence of two distinct, functioning kidneys positioned on each side of the spine, fused together at one of the poles. The incidence of this condition is approximately 1 case every 400-600 new births with a prevalence in the male sex with a ratio of 2:1. Even though these children aregenerally asymptomatic and the diagnosis is often incidental , some may develop symptoms due to complications, such as infections, nephrolithiasis and urinary tract obstruction. More rarely risks of neoplastic degeneration and renal damage are described following trauma to the abdomen and lumbosacral spine. This condition is also associated in up to a third of cases with other abnormalities: the most frequent affect the urinary tract and genitals; however, abnormalities affecting other organs or systems as well as well-defined syndromic pictures. Due to its frequent asymptomatic nature, horseshoe kidney is historically considered a condition with a good prognosis and rarely as a risk factor capable of reducing survival or predisposing the kidney to long-term damage.
The primary objective of the study is:
To assess the 'nephrological outcome' understood as 'prevalence of patients who developed' and 'survival time free from": chronic renal failure, proteinuria, hypertension nephrolithiasis, UTI, renal neoplasms and renal trauma.
The secondary objectives of the study are:
1. Prevalence of congenital and associated genito-urinary and systemic abnormalities; 2. Description of renal anatomical features; 3. Assessment of the usefulness of second level radiological investigations (VCUG, static renal scintigraphy, ddynamic renal scintigraphy).
Primary outcome measures
- Chronic kidney disease [Time frame: at baseline]
- Proteinuria [Time frame: at baseline]
- Hypertension [Time frame: at baseline]
Secondary outcome measures (6)
- Urinary tract infections [Time frame: at baseline]
- Nephrolithiasis [Time frame: at baseline]
- Renal neoplasms [Time frame: at baseline]
- Renal anatomical features [Time frame: at baseline]
- Renal anatomical features [Time frame: at baseline]
- Renal trauma [Time frame: at baseline]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna
Identifiers
NCT: NCT06728007 · HSK-PED-23-01