Horseshoe KidneyNCT06728007
Nephrological Outcome and Associated Congenital Anomalies in Pediatric Patients with Horseshoe Kidney
An observational study of Horseshoe Kidney, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
A retrospective, observational multicentre trial on the nephrological outcome and associated congenital anomalies in children with Horseshoe Kidney. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Horseshoe Kidney
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2025to 1 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients with a definitive diagnosis of another form of CAKUT during the diagnostic pathway.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138
Claudio La Scola, MD, PhD, 00390512144650, claudio.lascola@aosp.bo.it
Claudio La Scola
About this study
A retrospective, observational multicentre trial on the nephrological outcome and associated congenital anomalies in children with Horseshoe Kidney.
Read the 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:
- Prevalence of congenital and associated genito-urinary and systemic abnormalities;
- Description of renal anatomical features;
- Assessment of the usefulness of second level radiological investigations (VCUG, static renal scintigraphy, ddynamic renal scintigraphy).
- Conditions
- Horseshoe Kidney
- Keywords
- Horseshoe Kidney, Congenital anomalies, Children, CAKUT
- Medical subject headings
- Fused Kidney, Congenital Abnormalities, Cakut
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: at baseline
Hypertension
Arterial blood pressure ≥95th percentile for sex, age and height, on at least three different readings
Measured: at baseline
Secondary outcomes (6)
Urinary tract infections
Confirmed by urine analysis and urine culture in a compatible clinical picture
Measured: at baseline
Nephrolithiasis
Documented finding by imaging techniques (ultrasound and/or CT) of formations compatible with lithiasis formation
Measured: at baseline
Renal neoplasms
Diagnosis confirmed by imaging and histology of the neoplasm of renal origin (especially Wilms' tumour)
Measured: at baseline
Renal anatomical features
Renal length measured as bipolar diameter with renal hypoplasia defined as the presence of kidneys with DBP <5° centile reference for age and height
Measured: at baseline
Renal anatomical features
Ultrasound description of abnormalities of the renal parenchyma with renal dysplasia defined by the presence of alterations such as: hyperechogenicity, reduced cortico-middular differentiation, reduced cortical thickness due to age, presence of multiple cystic formations
Measured: at baseline
Renal trauma
Presence of instrumentally documented renal lesions (ultrasound and/or CT scan) following a traumatic episode
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start1 Jun 2025 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Horseshoe KidneyStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claudio La Scola, MD, PhD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06728007
- Sponsor's protocol ID
- HSK-PED-23-01
- Status last verified
- Nov 2024
- First submitted
- 3 Dec 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nephrological Outcome and Associated Congenital Anomalies in Pediatric Patients with Horseshoe Kidney
- ClinicalTrials.gov ID
- NCT06728007
- Acronym / sponsor ID
- HSK-PED-23-01
- Conditions
- Horseshoe Kidney
- Keywords
- Horseshoe Kidney, Congenital anomalies, Children, CAKUT
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 11 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Prevalence of congenital and associated genito-urinary and systemic abnormalities;
- Description of renal anatomical features;
- Assessment of the usefulness of second level radiological investigations (VCUG, static renal scintigraphy, ddynamic renal scintigraphy).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with a definitive diagnosis of another form of CAKUT during the diagnostic pathway.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Chronic kidney disease
Time frame: 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
Time frame: 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
Time frame: at baseline
Arterial blood pressure ≥95th percentile for sex, age and height, on at least three different readings
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Claudio La Scola, MD, PhD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Horseshoe Kidney, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claudio La Scola, MD, PhD (00390512144650, claudio.lascola@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic kidney disease (time frame: at baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.