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

NCT03949972 | Recruiting DMC

• 1 other identifier: 005
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 12

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.

Conditions

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

Keywords

Focal and Segmental Glomerulosclerosis; Focal & Segmental Glomerulosclerosis; FSGS; Minimal change disease; MCD; Nephrotic Syndrome

Outcome Measures

Primary Outcomes (6)

• Average Annual Change in estimated glomerular filtration rate (eGFR)

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

  5-15 years

• Incidence of End-stage Renal Disease (ESRD)

  Documented initiation of chronic renal replacement therapy regardless of type.

  5-15 years

• Incidence of Death

  Documented patient death due to any cause

  5-15 years

• Incidence of Kidney Transplantation

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

  5-15 years

• Changes in Quality of Life (adults patients)

  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.

  5-15 years

• Changes in Quality of Life (pediatric patients)

  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.

  5-15 years

Study Arms (2)

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.

Other: Biosampling

B -Adult Cohort

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

Other: Biosampling

Interventions

Biosampling OTHER

Biosampling at initial visit and follow-up visits

A - Pediatric Cohort; B -Adult Cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients until 18 years of age presenting with or diagnosed with idiopathic nephrotic syndrome or a biopsy-proven diagnosis of MCD or FSGS. Candidate participants need to be willing to provide written informed consent. Adult patients 18 years and above with a biopsy-proven diagnosis of primary or secondary FSGS or MCD. Candidate participants need to be willing to provide written informed consent.

You may qualify if:

• written informed consent
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Prof. Dr. Paul Brinkkoetter: lead
• German Research Foundation: collaborator
• Medical Faculty and the Faculty of Natural Sciences of the University of Cologne: collaborator
• Cluster of Excellence on Cellular Stress Responses in Ageing-Associated Diseases: collaborator
• Cologne Center for Genomics: collaborator

Study Sites (12)

University Hospital of Cologne

Cologne, North Rhine-Westphalia, 50937, Germany

RECRUITING

Uniklinik RWTH Aachen

Aachen, 52074, Germany

NOT YET RECRUITING

Charité University Hospital

Berlin, Germany

RECRUITING

Kindernierenzentrum Bonn

Bonn, 53127, Germany

RECRUITING

Kindernephrologie Dachau

Dachau, 85221, Germany

RECRUITING

University Hospital Erlangen

Erlangen, Germany

NOT YET RECRUITING

University Hospital Essen

Essen, 45147, Germany

RECRUITING

University Hospital Heidelberg

Heidelberg, 69120, Germany

RECRUITING

Klinikum St. Georg

Leipzig, 04129, Germany

RECRUITING

University Hospital Marburg

Marburg, Germany

RECRUITING

University Hospital Münster

Münster, Germany

RECRUITING

Klinikum Stuttgart

Stuttgart, 70174, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 37117201 DERIVED

Related Links

• CRU 329 Homepage

Biospecimen

Retention: SAMPLES WITH DNA

Blood (plasma, serum), urine, DNA, feces

MeSH Terms

Conditions

Glomerulosclerosis, Focal Segmental; Nephrosis, Lipoid; Macular dystrophy, corneal type 1; Nephrotic Syndrome

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Nephrosis

Study Officials

• Paul T Brinkkoetter, MD

  University Hospital of Cologne, Cologne, Germany

  STUDY DIRECTOR

Central Study Contacts

Paul T Brinkkoetter, MD

CONTACT

+49-221-478-4480; paul.brinkkoetter@uk-koeln.de

Linus A Voelker, MD

CONTACT

+49-221-478-4480; linus.voelker@uk-koeln.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant in Nephrology, Scientific Coordinator KFO 329

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: May 14, 2019
• Study Start: April 1, 2018
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2033
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: 5-15 years
• Access Criteria: Actively contributing to registry and approval by international steering committee.

Locations

DE (12)