The FOrMe Registry (The German Focal Segmental Glomerulosclerosis and Minimal Change Disease Registry)

NCT ID: NCT03949972

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2033-03-31

Brief Summary

In a monocentric, later multicentric prospective approach the FOrMe registry (The German Focal Segmental Glomerulosclerosis and Minimal Change Disease Registry) aims to generate a longitudinal cohort of 150 pediatric cases of idiopathic nephrotic syndrome and 350 adult cases of biopsy-proven Minimal Change Disease (MCD) or Focal and Segmental Glomerular Sclerosis (FSGS) over 10 years. The registry will provide a repository for biomaterials such as blood samples, DNA, urine, feces, and tissue biopsies that will be accessible to collaborators to facilitate future research on pathogenesis, diagnostics, and treatment.

Detailed Description

Idiopathic Nephrotic Syndrome is characterized by proteinuria, volume retention, hyperlipidemia, hypoalbuminemia. As Minimal Change Disease (MCD) represents by far the most prevalent underlying diagnosis in children older than 1 year, a kidney biopsy is usually deferred in these cases. In adolescence and adults, a kidney biopsy is crucial for the diagnosis because MCD and FSGS account for only 10-15 and 12-35 percent of all cases of nephrotic syndrome respectively. Pathomechanisms as well as optimal treatment remain elusive as systematic trials are scarce and hampered by low incidence and heterogenicity of the clinical presentation. To bridge this informational gap, the investigators identified the need for a German registry of pediatric and adult patients with idiopathic nephrotic syndrome (in children) and biopsy-proven MCD/FSGS (in adults).

The registry will record clinical data of participants regarding basic demographics, initial presentation, hereditary traits, disease course and treatment modalities as well as quality of life, concomitant diseases, and comedication. During the initial visit and to a lesser intent on follow-up visits, biomaterials (blood, urine, DNA, feces, tissue) will be collected and stored in a state-of-the art biobank. This material will be available to collaborators to support research on idiopathic nephrotic syndrome and MCD/FSGS. By the time of completion, the registry will provide data on clinical courses and outcome of approximately 500 patients that can easily be correlated with biomaterials giving insight into risk factors, prognostic parameters, and association with comorbidities.

Tissue sections of all patients that undergo kidney biopsy (all adult and some pediatric patients) will be digitalized, annotated, and analyzed by a panel of nephropathologists. Histopathologic features will be individually assessed and scored according to a set of descriptors that was developed and is used by the American NEPTUNE (Nephrotic Syndrome Study Network).

Conditions

Glomerulosclerosis, Focal Segmental; Minimal Change Disease; Idiopathic Nephrotic Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

A - Pediatric Cohort

Pediatric patients until 18 years of age presenting with or diagnosed with idiopathic nephrotic syndrome or a biopsy-proven diagnosis of MCD or FSGS.

Biosampling

Intervention Type: OTHER

Biosampling at initial visit and follow-up visits

B -Adult Cohort

Adult patients 18 years and above with a biopsy-proven diagnosis of primary or secondary FSGS or MCD.

Biosampling

Intervention Type: OTHER

Biosampling at initial visit and follow-up visits

Interventions

Biosampling

Biosampling at initial visit and follow-up visits

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• written informed consent
• 17 or less years of age
• idiopathic nephrotic syndrome

• 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

• 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Research Foundation

OTHER

Sponsor Role: collaborator

Medical Faculty and the Faculty of Natural Sciences of the University of Cologne

UNKNOWN

Sponsor Role: collaborator

Cluster of Excellence on Cellular Stress Responses in Ageing-Associated Diseases

UNKNOWN

Sponsor Role: collaborator

Cologne Center for Genomics

UNKNOWN

Sponsor Role: collaborator

Prof. Dr. Paul Brinkkoetter

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Paul Brinkkoetter

Consultant in Nephrology, Scientific Coordinator KFO 329

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Paul T Brinkkoetter, MD

Role: STUDY_DIRECTOR

University Hospital of Cologne, Cologne, Germany

Locations

University Hospital of Cologne

Cologne, North Rhine-Westphalia, Germany

Site Status: RECRUITING

Uniklinik RWTH Aachen

Aachen, , Germany

Site Status: NOT_YET_RECRUITING

Charité University Hospital

Berlin, , Germany

Site Status: RECRUITING

Kindernierenzentrum Bonn

Bonn, , Germany

Site Status: RECRUITING

Kindernephrologie Dachau

Dachau, , Germany

Site Status: RECRUITING

University Hospital Erlangen

Erlangen, , Germany

Site Status: NOT_YET_RECRUITING

University Hospital Essen

Essen, , Germany

Site Status: RECRUITING

University Hospital Heidelberg

Heidelberg, , Germany

Site Status: RECRUITING

Klinikum St. Georg

Leipzig, , Germany

Site Status: RECRUITING

University Hospital Marburg

Marburg, , Germany

Site Status: RECRUITING

University Hospital Münster

Münster, , Germany

Site Status: RECRUITING

Klinikum Stuttgart

Stuttgart, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Paul T Brinkkoetter, MD

Role: CONTACT

paul.brinkkoetter@uk-koeln.de

+49-221-478-4480

Linus A Voelker, MD

Role: CONTACT

linus.voelker@uk-koeln.de

+49-221-478-4480

Facility Contacts

paul brinkkoetter, MD

Role: primary

paul.brinkkoetter@uk-koeln.de

+49-221 478-4480

Lutz Weber, MD

Role: backup

lutz.weber@uk-koeln.de

+49 221 478-4319

Claudia Seikrit, MD

Role: primary

cseikrit@ukaachen.de

Kerstin Schröder

Role: backup

keschroeder@ukaachen.de

Jan P. Halbritter, MD, Prof.

Role: primary

jan.halbritter@charite.de

Silke Kasbohm

Role: backup

silke.kasbohm@charite.de

+ 49 30 450 514183

Gesa Gesa, MD

Role: primary

gesa.schalk@knz-bonn.de

+49 228 6883860

Katja Theissen

Role: backup

Katja.Theisen@knz-bonn.de

+49 228 6883860

Marcus Benz, MD

Role: primary

marcus.benz@uk-koeln.de

+49 8131-2995954

Alina Hilger, MD

Role: primary

alina.hilger@uk-erlangen.de

Matthias Galiano, MD

Role: backup

Matthias.Galiano@uk-erlangen.de

Lars Pape, MD, Prof.

Role: primary

lars.pape@uk-essen.de

+49 201 723 2810

Andreas Kribben, MD, Prof.

Role: backup

nephrologie@uk-essen.de

+49 201 723 1868

Burkhard Tönshoff, MD, Prof

Role: primary

Burkhard.Toenshoff@med.uni-heidelberg.de

+49 6221 56-4002

Maria Luisa Möller-Winheim

Role: backup

MariaLuisa.Moeller-Winheim@med.uni-heidelberg.de

+49 6221 56-310376

Ralph Wendt, MD

Role: primary

ralph.wendt@sanktgeorg.de

0341-909-4056

Stefanie Weber, MD

Role: primary

stefanie.weber@med.uni-marburg.de

+49 6421-5862659

Jördis Chrestensen-Fuchs

Role: backup

Joerdis.Chrestensen-Fuchs@uk-gm.de

+49 6421-5864807

Jens König, MD

Role: primary

Jens.Koenig@ukmuenster.de

Mee-Ling Maywald, MD

Role: backup

meeling.maywald@ukmuenster.de

Vedat Schwenger, Prof. MD

Role: primary

v.schwenger@klinikum-stuttgart.de

Castellie Cabata

Role: backup

c.cabata@klinikum-stuttgart.de

References

Osterholt T, Todorova P, Kuhne L, Ehren R, Weber LT, Grundmann F, Benzing T, Brinkkotter PT, Volker LA. Repetitive administration of rituximab can achieve and maintain clinical remission in patients with MCD or FSGS. Sci Rep. 2023 Apr 28;13(1):6980. doi: 10.1038/s41598-023-32576-7.

Reference Type: DERIVED

PMID: 37117201 (View on PubMed)

Related Links

http://www.podocyte.org

CRU 329 Homepage

Other Identifiers

005

Identifier Type: -

Identifier Source: org_study_id