Registry for patients with Focal Segmental Glomerulosclerosis and Minimal Change Disease
Official title: The FOrMe Registry (The German Focal Segmental Glomerulosclerosis and Minimal Change Disease Registry)
Run by University of Cologne · NCT03949972 · Data updated 2026-11-12
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 |
|---|---|
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | University of Cologne Academic / other |
| Locations | 12 sites (Cologne, North Rhine-Westphalia and 11 other locations) |
| Status | Recruiting |
| Started | April 1, 2018 |
| Main results expected | March 31, 2028 |
| Study ends | March 31, 2033 |
| Registry record updated | September 17, 2025 |
| Trial ID | NCT03949972 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include pediatric patients with idiopathic nephrotic syndrome and adults with biopsy-proven MCD or FSGS.
✕Probably not a fit
Patients with prior kidney transplants without biopsy-proven recurrence or those with other glomerular diseases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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University Hospital of Cologne
Cologne, North Rhine-Westphalia, Germany Recruiting -
Charité University Hospital
Berlin, Germany Recruiting -
Kindernierenzentrum Bonn
Bonn, Germany Recruiting -
Kindernephrologie Dachau
Dachau, Germany Recruiting -
University Hospital Essen
Essen, Germany Recruiting -
University Hospital Heidelberg
Heidelberg, Germany Recruiting
Show 6 more locations
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Klinikum St. Georg
Leipzig, Germany Recruiting -
University Hospital Marburg
Marburg, Germany Recruiting -
University Hospital Münster
Münster, Germany Recruiting -
Klinikum Stuttgart
Stuttgart, Germany Recruiting -
Uniklinik RWTH Aachen
Aachen, Germany Not yet recruiting -
University Hospital Erlangen
Erlangen, Germany Not yet recruiting
Study contacts
- Study coordinator: Paul T Brinkkoetter, MD
- Email: paul.brinkkoetter@uk-koeln.de
- Phone: +49-221-478-4480
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Exploring experiences of patients and parents dealing with swelling from Nephrotic Syndrome
This study talks to patients and parents about their experiences with swelling from Nephrotic Syndrome to help create better ways to measure how new treatments work.
-
Testing ManNAc for treating kidney disease FSGS
This study is testing if a new oral treatment called ManNAc can help adults with kidney disease FSGS by reducing protein levels in their urine and checking how safe it is over 12 weeks.
-
Evaluating WAL0921 for kidney diseases
This study is testing a new drug called WAL0921 to see if it can help people with different types of kidney diseases feel better.
-
Observational study on kidney transplant recurrence in FSGS and MCD
This study is looking at patients with kidney diseases called FSGS and MCD who have had or will have a kidney transplant to see how often these diseases come back afterward.
-
Vagus nerve stimulation for treating nephrotic syndrome in children
This study is testing whether a new treatment using vagus nerve stimulation can help children aged 3 to 17 with nephrotic syndrome feel better and reduce their symptoms.
-
Using vagus nerve stimulation to treat nephrotic syndrome in children
This study is testing if a new type of nerve stimulation can help children with steroid-resistant nephrotic syndrome feel better over 26 weeks.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.