Actively Recruiting

All Genders
NCT03949972

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

Led by Prof. Dr. Paul Brinkkoetter · Updated on 2025-09-17

500

Participants Needed

12

Research Sites

782 weeks

Total Duration

On this page

Sponsors

P

Prof. Dr. Paul Brinkkoetter

Lead Sponsor

G

German Research Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

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
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 12 locations

1

University Hospital of Cologne

Cologne, North Rhine-Westphalia, Germany, 50937

Actively Recruiting

2

Uniklinik RWTH Aachen

Aachen, Germany, 52074

Not Yet Recruiting

3

Charité University Hospital

Berlin, Germany

Actively Recruiting

4

Kindernierenzentrum Bonn

Bonn, Germany, 53127

Actively Recruiting

5

Kindernephrologie Dachau

Dachau, Germany, 85221

Actively Recruiting

6

University Hospital Erlangen

Erlangen, Germany

Not Yet Recruiting

7

University Hospital Essen

Essen, Germany, 45147

Actively Recruiting

8

University Hospital Heidelberg

Heidelberg, Germany, 69120

Actively Recruiting

9

Klinikum St. Georg

Leipzig, Germany, 04129

Actively Recruiting

10

University Hospital Marburg

Marburg, Germany

Actively Recruiting

11

University Hospital Münster

Münster, Germany

Actively Recruiting

12

Klinikum Stuttgart

Stuttgart, Germany, 70174

Actively Recruiting

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Research Team

P

Paul T Brinkkoetter, MD

CONTACT

L

Linus A Voelker, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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