Active — Not RecruitingNot Applicable

New Analytic Tools for aHUS and C3G Diagnosis

Italy180 participantsStarted 2023-07-01

Plain-language summary

This protocol is part of a larger project, COMPRare (COMPlement-mediated Rare kidney diseases), which has been financed on behalf of the EJP RD (European Joint Programme on Rare Diseases) program of EU and is leaded by a scientific consortium from 7 European countries. The partners (P) of the consortium are: P1. Radboudumc Amalia Children's Hospital (The Netherlands) P2. Semmelweis University (Hungary) P3. Cordeliers Research Center (France) P4. Max Delbruck Center for Molecular Medicine (Germany) P5. Istituto di Ricerche Farmacologiche Mario Negri (Italy) P6. Lund University (Sweden) P7. Lille University (France) The general aim of the project is to define new diagnostic tools for complement activation in order to improve patients stratification and follow-up, thereby affecting time and choice of treatment in patients with aHUS and C3G. Particularly, the specific objectives of the COMPRare are: * To develop new standardized analytic assays thereby identifying specific complement prognostic biomarkers for early diagnosis, classification, improved monitoring and treatment of patients with aHUS and C3G; * To in-depth characterize patients' complement abnormalities in blood, in patient-derived cells and in kidney biopsies; * To identify strategies to classify VUS/LPV * To find new pathophysiological pathways involved in aHUS and C3G for further improving disease diagnosis, monitoring and treatment. The results of these studies will form the basis of personalized treatment with existing and upcoming complement inhibitory drugs for these rare complement-mediated kidney diseases.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Determination of assay sensitivity and specificity

Timeframe: At day 0

Trial details

NCT IDNCT05985122

SponsorMario Negri Institute for Pharmacological Research

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10

View on ClinicalTrials.gov More Hemolytic-Uremic Syndrome trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.