NCT05927467 Eurbio-Alport (RaDiCo Cohort) (RaDiCo Eurbio-Alport)
| NCT ID | NCT05927467 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institut National de la Santé Et de la Recherche Médicale, France |
| Condition | Alport Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 700 participants |
| Start Date | 2017-05-09 |
| Primary Completion | 2026-06-30 |
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 700 participants in total. It began in 2017-05-09 with a primary completion date of 2026-06-30.
⚠ 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
Alport syndrome is a rare, inherited condition characterized by a combination of glomerular nephropathy progressing to kidney failure, deafness, and eye involvement. This disease is associated with mutations in the genes encoding one of the three IV collagen chains expressed in the glomerular basement membrane. Significant progress has been made in understanding the molecular mechanisms responsible for the disease, but relatively little in understanding the progression of renal failure and in the area of therapeutics. We have shown in a retrospective European study that blockers of the renin angiotensin system may slow disease progression, but no controlled studies have been performed. Finally, innovative therapies (anti-micro-RNA, stem cells) have recently shown their effectiveness in animal models of the disease, and industrials are planning to quickly carry out phase 1 trials to test molecules. Carrying out therapeutic trials in humans will require full knowledge of the natural history of the disease (isolated hematuria, microalbuminuria, macroalbuminuria, renal failure and its progression) and gathering a sufficient number of patients, especially in the early stages. These trials and the indications for treatments would be greatly facilitated by the discovery of biomarkers that make it possible to predict the progression to renal failure earlier than the onset of proteinuria. The study aims to: * Establish a European database on Alport syndrome to assess the natural history of the disease. * To investigate the impact of the disease on the educational and professional life of patients and their families, and on the adherence and tolerance to renin-angiotensin system blockers prescribed to proteinuric patients. * Investigate access to molecular diagnostics and genetic counseling, as well as identify biomarkers that can predict progression of kidney disease. This project will be carried out at a French level with the support and participation of the very active renal rare disease sector, in collaboration with various countries wishing to participate.
Eligibility Criteria
Inclusion Criteria: * Diagnosis of AS based on electron microscopic examination of the renal biopsy and/or molecular studies and/or abnormal expression of type IV collagen chains on skin and/or glomerular basement membranes. * Signed informed consent Exclusion Criteria: \- No exclusion criteria
Contact & Investigator
Laurence Heidet, PHD
PRINCIPAL INVESTIGATOR
INSERM U933
Frequently Asked Questions
Who can join the NCT05927467 clinical trial?
This trial is open to participants of all sexes, studying Alport Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05927467 currently recruiting?
Yes, NCT05927467 is actively recruiting participants. Contact the research team at laurence.heidet@aphp.fr for enrollment information.
Where is the NCT05927467 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT05927467 clinical trial?
NCT05927467 is sponsored by Institut National de la Santé Et de la Recherche Médicale, France. The principal investigator is Laurence Heidet, PHD at INSERM U933. The trial plans to enroll 700 participants.