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

Last updated: May 7, 2024
Sponsor: Prof. Dr. Paul Brinkkoetter
Overall Status: Active - Recruiting

Phase

N/A

Condition

Kidney Failure (Pediatric)

Nephropathy

Nephrotic Syndrome

Treatment

Biosampling

Clinical Study ID

NCT03949972
005
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: Biosampling
Phase:
Study Start date:
April 01, 2018
Estimated Completion Date:
March 31, 2033

Study 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).

Connect with a study center

  • University Hospital of Cologne

    Cologne, NRW 50937
    Germany

    Active - Recruiting

  • Charité University Hospital

    Berlin,
    Germany

    Active - Recruiting

  • Kindernierenzentrum Bonn

    Bonn, 53127
    Germany

    Active - Recruiting

  • Kindernephrologie Dachau

    Dachau, 85221
    Germany

    Active - Recruiting

  • University Hospital Erlangen

    Erlangen,
    Germany

    Site Not Available

  • University Hospital Essen

    Essen, 45147
    Germany

    Active - Recruiting

  • University Hospital Greifswald

    Greifswald,
    Germany

    Site Not Available

  • University Hospital Heidelberg

    Heidelberg, 69120
    Germany

    Active - Recruiting

  • Klinikum St. Georg

    Leipzig, 04129
    Germany

    Active - Recruiting

  • University Hospital Marburg

    Marburg,
    Germany

    Active - Recruiting

  • University Hospital Münster

    Münster,
    Germany

    Active - Recruiting

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