Daily pattern of urinary copper in people with Wilson disease
Official title: Circadian Variation of Urinary Copper Excretion in Wilson Disease Patients Treated With Chelators or Zinc Salts
Run by Hospices Civils de Lyon · NCT06430359 · Data updated 2026-11-12
This study will test whether urinary copper levels change during the day in people with Wilson disease and whether single spot urine samples can reflect 24-hour copper loss.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 6 Years to 70 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 1 site (Bron, Rhone) |
| Status | Recruiting |
| Started | January 10, 2025 |
| Main results expected | February 10, 2027 |
| Study ends | February 10, 2027 |
| Registry record updated | January 15, 2026 |
| Trial ID | NCT06430359 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people aged 6–70 with a confirmed Wilson disease diagnosis (Leipzig score >4), on stable D-penicillamine, trientine, or zinc therapy, and able to perform a 24-hour urine collection.
✕Probably not a fit
Patients who recently changed treatment, have undergone liver transplantation, have severe renal failure (GFR < 30 ml/min), are on long-term diuretics or corticosteroids, or cannot provide consent are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study will collect serial spot urine samples, a 24-hour urine, and blood tests from participants with confirmed Wilson disease who are on stable chelation or zinc therapy. Urinary copper will be measured across the day to characterize any circadian variation and to compare spot sample results with total 24-hour copper excretion. The trial includes patients aged 6–70 who can perform 24-hour urine collection and excludes those with recent treatment changes, liver transplantation, or severe renal failure. Results aim to clarify whether timing of urine collection can improve monitoring and reduce the burden of 24-hour collections.
Why it matters
Potential benefit: If successful, the findings could make monitoring easier by identifying optimal timing for spot urine tests and reducing reliance on 24-hour collections.
How similar studies have gone: Small studies in healthy volunteers suggest daily rhythms in urinary copper, but there is limited prior evidence specifically in people with Wilson disease, so this application is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with a confirmed diagnosis of Wilson's Disease (Leipzig score ˃4). * Age ≥ 6 years and ≤70 years. * Patient able to perform 24h urine. * Current treatment with D-Pencillamine, Trientine or Zinc. * Non-opposition of patient and/or legal representatives for minor patients. Exclusion Criteria: * Patients who had a change in treatment within the last 6 months before the inclusion * Patients who have undergone liver transplantation * Patients with known chronic renal failure (GFR \< 30 ml/min) * Patients on long-term diuretic or corticosteroid therapy * Persons deprived of liberty by a judicial or administrative decision * Patient under judicial protection, unable to express consent
Where it's running
-
Service de Gastroentérologie, Hépatologie et Nutrition Pédiatriques - Hôpital Femme Mère Enfant
Bron, Rhone, France Recruiting
Study contacts
- Study coordinator: Eduardo COUCHONNAL, Dr
- Email: eduardo.couchonnal-bedoya@chu-lyon.fr
- Phone: 04 27 35 70 50
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.