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

  • End date
    Mar 31, 2033
  • participants needed
  • sponsor
    Prof. Dr. Paul Brinkkoetter
Updated on 7 February 2022
kidney transplant
nephrotic syndrome
minimal change disease


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.


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).

Condition Glomerulosclerosis, Focal Segmental, Minimal Change Disease, Idiopathic Nephrotic Syndrome
Treatment Biosampling
Clinical Study IdentifierNCT03949972
SponsorProf. Dr. Paul Brinkkoetter
Last Modified on7 February 2022


Yes No Not Sure

Inclusion Criteria

written informed consent
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

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
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