NCT07075393 Description of Renal Involvement in Wilson's Disease
| NCT ID | NCT07075393 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondation Ophtalmologique Adolphe de Rothschild |
| Condition | Wilson Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-07-22 |
| Primary Completion | 2029-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2026-07-22 with a primary completion date of 2029-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Wilson's disease (WD) is a rare genetic disorder that leads to copper accumulation in various tissues, including the liver, nervous system, heart, and kidneys. Renal involvement in WD has been poorly studied, and systematic screening is not currently recommended. Indirect renal complications are the most common, such as hepatorenal and cardiorenal syndromes, as well as severe complications like hemolysis or rhabdomyolysis. However, literature suggests that copper may exert a direct toxic effect on renal tubular cells, leading to both proximal and distal tubular dysfunction. These may manifest through often subtle signs, such as aminoaciduria, glycosuria, hypouricemia, and low-molecular-weight proteinuria. Electrolyte imbalances of varying severity may also occur, including hypokalemia, which can cause muscle cramps and cardiac arrhythmias, as well as acid-base disorders (proximal or distal renal tubular acidosis), and/or phosphate-calcium metabolism abnormalities (phosphate diabetes and hypercalciuria). These latter issues may lead to complications such as urinary stones, nephrocalcinosis, and even fracture-related osteoporosis. In addition, long-term treatment with D-penicillamine (DPA), a common therapy for WD, can cause renal damage in 10-20% of cases, mainly affecting the glomeruli. This includes membranous nephropathy, severe proliferative glomerulonephritis, or nephrotic syndrome with minimal change disease. Without appropriate monitoring and preventive care, both direct and indirect renal complications can lead to acute or chronic kidney failure. It is likely that the prevalence and systemic impact of renal involvement in WD are currently underestimated.
Eligibility Criteria
Inclusion Criteria: * Patient aged 7 years and older * Diagnosed with Wilson's disease, with a Leipzig score ≥ 4 Exclusion Criteria: * Patient who has undergone organ transplantation * Known renal comorbidity unrelated to Wilson's disease * Pregnant or breastfeeding woman
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07075393 clinical trial?
This trial is open to participants of all sexes, aged 7 Years or older, studying Wilson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07075393 currently recruiting?
Yes, NCT07075393 is actively recruiting participants. Contact the research team at ayavchitz@for.paris for enrollment information.
Where is the NCT07075393 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT07075393 clinical trial?
NCT07075393 is sponsored by Fondation Ophtalmologique Adolphe de Rothschild. The trial plans to enroll 150 participants.