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

ConditionsGlomerulosclerosis, Focal SegmentalMinimal Change DiseaseIdiopathic Nephrotic Syndrome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorProf. Dr. Paul Brinkkoetter

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

written informed consent

17 or less years of age

idiopathic nephrotic syndrome

written informed consent

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Biosampling

    Other intervention

    Biosampling at initial visit and follow-up visits

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: A - Pediatric Cohort1 intervention
Group B: B -Adult Cohort1 intervention

Trial outcomes

Primary outcomes

1

Average Annual Change in estimated glomerular filtration rate (eGFR)

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

Time frame
5-15 years
2

Incidence of End-stage Renal Disease (ESRD)

Documented initiation of chronic renal replacement therapy regardless of type.

Time frame
5-15 years
3

Incidence of Death

Documented patient death due to any cause

Time frame
5-15 years
4

Incidence of Kidney Transplantation

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

Time frame
5-15 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Prof. Dr. Paul Brinkkoetter

Lead sponsor

University of Cologne

Sponsor institution

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

Source ClinicalTrials.gov
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