Repetitive administration of rituximab can achieve and maintain clinical remission in patients with MCD or FSGS.
Thomas Osterholt, Polina Todorova, Lucas Kühne...
https://pubmed.ncbi.nlm.nih.gov/37117201Actively Recruiting
All Genders
ID03949972
The FOrMe Registry: German Registry for Focal Segmental Glomerulosclerosis and Minimal Change Disease
Led by Prof. Dr. Paul Brinkkoetter · Updated on 2025-09-17
500
Participants Needed
12
Research Sites
260 weeks
Total Duration
On this page
Sponsors
P
Prof. Dr. Paul Brinkkoetter
Lead Sponsor
G
German Research Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are gathering detailed information on patients with idiopathic nephrotic syndrome, Minimal Change Disease (MCD), and Focal Segmental Glomerulosclerosis (FSGS) through the FOrMe registry. This registry seeks to collect data from about 150 children and 350 adults over 10 years to better understand the causes, diagnosis, and treatment of these kidney disorders. The study includes both kids with idiopathic nephrotic syndrome and adults with biopsy-confirmed MCD or FSGS, addressing gaps caused by the rarity and complexity of these conditions. Participants will be enrolled in two groups: pediatric patients up to 18 years old diagnosed with idiopathic nephrotic syndrome or biopsy-proven MCD or FSGS, and adults aged 18 or older with biopsy-confirmed primary or secondary FSGS or MCD. During initial and follow-up visits, biological samples such as blood, urine, DNA, feces, and kidney tissue will be collected and stored in a biobank. Adult and some pediatric patients who undergo kidney biopsy will have their tissue digitally analyzed by experts to assess histopathologic features. Throughout the study, clinical data on demographics, disease course, treatments, quality of life, and related health conditions will be recorded. Researchers will monitor kidney function changes, incidence of kidney failure, death, transplants, and quality of life over 5 to 15 years. The study offers long-term observation with biomaterial access to support future research, helping identify risk factors and predictors for outcomes in these kidney diseases.
CONDITIONS
Brief Title
The FOrMe Registry (The German Focal Segmental Glomerulosclerosis and Minimal Change Disease Registry)
Who Can Participate
All Genders
Eligibility Criteria
You may qualify if you...
- Written informed consent is provided
- For pediatric cohort: age 17 years or younger
- Diagnosed with idiopathic nephrotic syndrome (pediatric cohort)
- For adult cohort: age 18 years or older
- Biopsy-proven primary or secondary FSGS or MCD, or biopsy-proven recurrence of disease in kidney transplant (adult cohort)
You will not qualify if you...
- Prior kidney transplant without biopsy-proven recurrence
- Diagnosis of other glomerular disease causing secondary MCD or FSGS
- Refusal to provide written informed consent
- Anticipated inability to comply with the visit schedule
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surveillance
Duration - Up to 15 years
Participants are observed to collect clinical data, biomaterials, and quality of life information throughout their disease course.
Initial visit and follow-up visits for biosampling and clinical data collection
Trial Site Locations
Total: 12 locations
1
University Hospital of Cologne
Cologne, North Rhine-Westphalia, Germany, 50937
Actively Recruiting
2
Uniklinik RWTH Aachen
Aachen, Germany, 52074
Not Yet Recruiting
3
Charité University Hospital
Berlin, Germany
Actively Recruiting
4
Kindernierenzentrum Bonn
Bonn, Germany, 53127
Actively Recruiting
5
Kindernephrologie Dachau
Dachau, Germany, 85221
Actively Recruiting
6
University Hospital Erlangen
Erlangen, Germany
Not Yet Recruiting
7
University Hospital Essen
Essen, Germany, 45147
Actively Recruiting
8
University Hospital Heidelberg
Heidelberg, Germany, 69120
Actively Recruiting
9
Klinikum St. Georg
Leipzig, Germany, 04129
Actively Recruiting
10
University Hospital Marburg
Marburg, Germany
Actively Recruiting
11
University Hospital Münster
Münster, Germany
Actively Recruiting
12
Klinikum Stuttgart
Stuttgart, Germany, 70174
Actively Recruiting
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Research Team
P
Paul T Brinkkoetter, MD
L
Linus A Voelker, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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