Registry for patients with Focal Segmental Glomerulosclerosis and Minimal Change Disease
The FOrMe Registry (The German Focal Segmental Glomerulosclerosis and Minimal Change Disease Registry)
This study is setting up a registry to collect health information and samples from kids and adults with certain kidney diseases to help researchers learn more about them and improve treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Sex | All |
| Sponsor | University of Cologne Academic / other |
| Locations | 12 sites (Cologne, North Rhine-Westphalia and 11 other locations) |
| Trial ID | NCT03949972 on ClinicalTrials.gov |
What this trial studies
The FOrMe registry aims to create a longitudinal cohort of 150 pediatric cases of idiopathic nephrotic syndrome and 350 adult cases of biopsy-proven Minimal Change Disease (MCD) or Focal Segmental Glomerular Sclerosis (FSGS) over a period of 10 years. This observational study will collect clinical data and biomaterials such as blood, urine, DNA, feces, and tissue biopsies from participants to facilitate future research on the pathogenesis, diagnostics, and treatment of these conditions. The registry will serve as a valuable resource for understanding the disease course and outcomes in affected patients.
Who should consider this trial
Good fit: Ideal candidates include pediatric patients with idiopathic nephrotic syndrome and adults with biopsy-proven MCD or FSGS.
Not a fit: Patients with prior kidney transplants without biopsy-proven recurrence or those with other glomerular diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could enhance understanding of idiopathic nephrotic syndrome and improve treatment strategies for patients with MCD and FSGS.
How similar studies have performed: While there have been few systematic trials due to the rarity of these conditions, the establishment of registries like this one has shown promise in other areas of nephrology.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria (cohort A): * written informed consent * 17 or less years of age * idiopathic nephrotic syndrome Inclusion Criteria (cohort B): * written informed consent * older or equal to 18 years of age * biopsy-proven primary or secondary FSGS or MCD or biopsy-proven recurrence of disease in kidney transplant. Exclusion Criteria (both cohorts): * Prior kidney transplant without biopsy-proven recurrence * A clinical diagnosis of other glomerular disease resulting in secondary MCD or FSGS as judged by the treating physicians. * Refusal to provide written informed consent * (Anticipated) incompliance with visit schedule
Where this trial is running
Cologne, North Rhine-Westphalia and 11 other locations
- University Hospital of Cologne — Cologne, North Rhine-Westphalia, Germany (Recruiting)
- Uniklinik RWTH Aachen — Aachen, Germany (Not_yet_recruiting)
- Charité University Hospital — Berlin, Germany (Recruiting)
- Kindernierenzentrum Bonn — Bonn, Germany (Recruiting)
- Kindernephrologie Dachau — Dachau, Germany (Recruiting)
- University Hospital Erlangen — Erlangen, Germany (Not_yet_recruiting)
- University Hospital Essen — Essen, Germany (Recruiting)
- University Hospital Heidelberg — Heidelberg, Germany (Recruiting)
- Klinikum St. Georg — Leipzig, Germany (Recruiting)
- University Hospital Marburg — Marburg, Germany (Recruiting)
- University Hospital Münster — Münster, Germany (Recruiting)
- Klinikum Stuttgart — Stuttgart, Germany (Recruiting)
Study contacts
- Study coordinator: Paul T Brinkkoetter, MD
- Email: paul.brinkkoetter@uk-koeln.de
- Phone: +49-221-478-4480
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.