New diagnostic tools for kidney diseases
Towards the Most Accurate Diagnosis and Monitoring of Complement-mediated Rare Kidney Diseases
This study is testing new tools to help doctors better diagnose and treat rare kidney diseases like aHUS and C3G.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Sex | All |
| Sponsor | Mario Negri Institute for Pharmacological Research Academic / other |
| Drugs / interventions | Eculizumab, Ravulizumab |
| Locations | 1 site (Ranica, BG) |
| Trial ID | NCT05985122 on ClinicalTrials.gov |
What this trial studies
This project aims to develop standardized analytic assays to improve the diagnosis and treatment of atypical Hemolytic Uremic Syndrome (aHUS) and C3 Glomerulopathies (C3G). It is part of the COMPRare initiative, which involves a consortium of seven European institutions working together to address the challenges of accurate diagnosis in these rare kidney conditions. The study focuses on identifying specific complement activation markers and improving patient stratification for better treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates include male and female patients of all ages diagnosed with C3G or aHUS, either in acute phase or remission.
Not a fit: Patients with Stx-associated HUS or TTP, as well as those who have undergone plasma therapy within two weeks of blood sampling, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and timely diagnoses for patients with aHUS and C3G, ultimately improving treatment choices and outcomes.
How similar studies have performed: Other studies have shown promise in developing diagnostic tools for complement-mediated kidney diseases, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Aim 1 Inclusion Criteria: * Male and female patients (children and adults) with C3G diagnosis * Biobank written informed consent Aim 2 Inclusion criteria * Male and female patients (children and adults) with aHUS diagnosis in acute phase (before any treatment), or in remission either untreated or undergoing anti-C5 treatment at standard dosing * Written informed consent Exclusion criteria * Stx-associated HUS * TTP (ADAMTS13\<10%) * Plasma therapy within 2 weeks from blood sampling
Where this trial is running
Ranica, BG
- Centro di Ricerche Cliniche per le Malattie Rare "Aldo e Cele Daccò" — Ranica, Bg, Italy (Recruiting)
Study contacts
- Principal investigator: Marina Noris, PhD — Istituto Di Ricerche Farmacologiche Mario Negri
- Study coordinator: Marina Noris, PhD
- Email: marina.noris@marionegri.it
- Phone: +3903545351
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.