Evaluating the Role of Complement Activation in IgA Nephropathy Severity
Study of the Link Between Complement Activation and IgA Nephropathy Severity
This study is trying to see if measuring certain markers related to complement activation can help identify how severe IgA nephropathy is and which patients might be at risk for it getting worse.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT05234463 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the significance of complement activation as a biomarker for the severity and progression of IgA nephropathy (IgAN) in patients with confirmed diagnoses. By analyzing a combination of biomarkers related to complement activation, the study seeks to identify patient subsets at risk for disease progression. The research is conducted at the Nephrology Department of Strasbourg University Hospital and includes both primitive and secondary forms of IgAN, regardless of kidney function or transplantation history. The findings could enhance understanding of IgAN and inform future complement-targeting therapies.
Who should consider this trial
Good fit: Ideal candidates include adult patients with biopsy-proven IgA nephropathy, regardless of their kidney function or transplantation history.
Not a fit: Patients with active infections, recent vaccinations, or those currently receiving complement inhibitors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved risk stratification and personalized treatment approaches for patients with IgA nephropathy.
How similar studies have performed: While the role of complement activation in IgAN is being explored, this specific approach to stratifying disease severity is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients, male or female, with a biopsy proven IgA nephropathy. * Primitive and secondary forms can be included * Regardless of the date of diagnosis and the level of kidney function * With or without past of kidney transplantation * Followed in the Nephrology Department, Strasbourg University Hospital * Signed informed consent Exclusion Criteria: * Active or recent infectious or inflammatory syndrome (\<2 months), recent vaccination (\<2 months), ongoing acute humoral rejection treatment, treatment with plasma exchanges (\<2 months), current treatment with complement inhibitors * Impossibility of giving informed information (emergency situation, difficulties in understanding, etc.) * Subject under safeguard of justice, guardianship or curatorship
Where this trial is running
Strasbourg
- Service de néphrologie — Strasbourg, France (Recruiting)
Study contacts
- Study coordinator: Sophie Ohlmann- Caillard, MD
- Email: sophie.ohlmann@chru-strasbourg.fr
- Phone: 03.88.11.67.68
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.