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Simple urine test may spot kidney risk in spina bifida

NCT ID NCT06041334

Knowledge-focused Sponsor: Rennes University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing whether certain substances in urine (called biomarkers) can predict kidney damage in people with spina bifida. Researchers will measure these biomarkers in 50 patients and compare them to a standard risk score. The goal is to find a non-invasive way to monitor kidney health, but this is an observational study, not a treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a simple urine test to predict kidney damage risk in spina bifida patients, helping doctors intervene earlier.
What could go wrong
This is a small, early-stage observational study, not a treatment trial. The biomarkers may not reliably predict kidney damage, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Spina patients consulted as part of the multidisciplinary consultation of the spina bifida rare disease reference centre; * Written consent to participate in the research. * Compulsory membership of a social security scheme Exclusion Criteria: * Patients with a non-continuous trans ileal urinary diversion ; * Patients with enterocystoplasty; * Untreated bacteriuria at the time of urodynamic assessment and urine sample collection; * History of urinary tract tumour; * History of histologically proven interstitial cystitis; * Persons under legal protection (safeguard of justice, curatorship, guardianship); * Persons deprived of their liberty. * Women claiming to be pregnant

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Conditions

The condition(s) this trial relates to.

spina bifida

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Spina bifida

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Rennes University Hospital

    RECRUITING

    Rennes, CHU de Rennes, 35033, France

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