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NCT Number: NCT03949972

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

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.

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Key information

Conditions

Glomerulosclerosis, Focal Segmental Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Idiopathic Nephrotic Syndrome Kidney Diseases Macular dystrophy, corneal type 1 Male Urogenital Diseases Minimal Change Disease Nephritis Nephrosis Nephrosis, Lipoid Nephrotic Syndrome Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Cologne, Cologne, North Rhine-Westphalia, Germany

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biosampling

Other

Biosampling at initial visit and follow-up visits

Primary outcomes

  1. Average Annual Change in estimated glomerular filtration rate (eGFR)

    Time frame: 5-15 years

    Outcome measure: eGFR loss in ml/min/year. Higher values are considered worse outcome.

  2. Incidence of End-stage Renal Disease (ESRD)

    Time frame: 5-15 years

    Documented initiation of chronic renal replacement therapy regardless of type.

  3. Incidence of Death

    Time frame: 5-15 years

    Documented patient death due to any cause

  4. Incidence of Kidney Transplantation

    Time frame: 5-15 years

    Documented kidney transplantation regardless of type (living donor, cadaveric donor)

  5. Changes in Quality of Life (adults patients)

    Time frame: 5-15 years

    Patient-reported outcome will be assessed using Quality of Life questionnaires at regular intervals using the SF-36 questionnaire.

    For reference see https://www.rand.org/health-care/surveys_tools/mos/36-item-short-form/scoring.html The SF-36 questionnaire measures eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. All items are scored so that a high score defines a more favorable health state. Lowest and highest possible scores are 0 and 100. Scores represent the percentage of total possible score achieved.

    Original publication: Ware, J.E., Jr., & Sherbourne, C.D. "The MOS 36-Item Short-Form Health Survey (SF-36): I. Conceptual Framework and Item Selection,". Medical Care, 30:473-483, 1992.

  6. Changes in Quality of Life (pediatric patients)

    Time frame: 5-15 years

    Patient-reported outcome will be assessed using Quality of Life questionnaires at regular intervals using the PedsQL questionnaire.

    For reference see https://www.pedsql.org/score.html The PedSQL questionnaire measures four health concepts: Physical Functioning, Emotional Functioning, Social Functioning, and School Functioning. Items are reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better HRQOL (Health-Related Quality of Life). To create Scale Scores, the mean is computed as the sum of the items over the number of items answered (this accounts for missing data). To create the Total Scale Score, the mean is computed as the sum of all the items over the number of items answered on all the Scales.

Study contacts

Contact information is provided by the study sponsor or research team.

Linus A Voelker, MD

CONTACT

[email protected]

+49-221-478-4480

Paul T Brinkkoetter, MD

CONTACT

[email protected]

+49-221-478-4480

Sponsors and collaborators

Lead sponsor

Prof. Dr. Paul Brinkkoetter

Other

Collaborators

  • Cluster of Excellence on Cellular Stress Responses in Ageing-Associated Diseases
  • Cologne Center for Genomics
  • German Research Foundation
  • Medical Faculty and the Faculty of Natural Sciences of the University of Cologne

Registry information

Acronym: FOrMe

Important dates

Study start
2018
Primary completion
2028
Study completion
2033
First posted
May 14, 2019
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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