Registry and biobank for resistant nephrotic syndrome treatment responses
ARREST-NEPHROSIS - Austrian Resistant Nephrotic Syndrome Treatment Response Registry and Biobank
This study is collecting information from patients with resistant nephrotic syndrome to see how different treatments work and to help find better options for the future.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | N/A to 75 Years |
| Sex | All |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 1 site (Vienna) |
| Trial ID | NCT06162546 on ClinicalTrials.gov |
What this trial studies
The ARREST-NEPHROSIS initiative aims to gather real-world data on treatment patterns and outcomes for patients with resistant nephrotic syndrome, particularly those with focal segmental glomerulosclerosis. This observational registry will facilitate networking among patients, families, and clinicians while establishing a biobank for future research into biomarkers and therapies. By creating a comprehensive patient database, the project seeks to enhance recruitment for clinical trials of new treatments. The study addresses the urgent need for effective therapies in a population that is often overlooked due to the rarity of the condition.
Who should consider this trial
Good fit: Ideal candidates include patients with resistant nephrotic syndrome who have a persistent urinary protein-to-creatinine ratio greater than 1.0 g/g and an eGFR above 30 ml/min.
Not a fit: Patients who are steroid-dependent or have frequently relapsing disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this initiative could lead to improved treatment options and outcomes for patients with resistant nephrotic syndrome.
How similar studies have performed: While there is limited data on similar registries for this specific condition, patient registries have been successful in other rare diseases, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Resistant to standard Immunosuppressive agents (if clinically indicated, e.g. primary/non-genetic forms) * Persistent urinary protein-to-creatinine (UP/C) ratio \>1.0 g/g * eGFR \> 30 ml/min per 1.73 m2 * biopsy or a disease-causing genetic mutation associated with nephrotic syndrome Exclusion Criteria: * Inability or unwillingness to comply with repeated assessments * Objections against participation at discretion of the investigator * Secondary * Patients with steroid-dependence/frequently relapsing disease (but achievement of complete remission)
Where this trial is running
Vienna
- Division of Pediatric Nephrology and Gastroenterology, Department of Pediatrics and Adolescent Medicine, Comprehensive Center for Pediatrics, Medical University of Vienna, 1090 Vienna, Austria. — Vienna, Austria (Recruiting)
Study contacts
- Study coordinator: Christoph Aufricht, Prof. MD
- Email: christoph.aufricht@meduniwien.ac.at
- Phone: +4314040021115
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.