Glomerulosclerosis, Focal SegmentalFOrMeNCT03949972
The FOrMe Registry (The German Focal Segmental Glomerulosclerosis and Minimal Change Disease Registry)
An observational study of Glomerulosclerosis, Focal Segmental and Minimal Change Disease, run by Prof. Dr. Paul Brinkkoetter at 12 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Glomerulosclerosis, Focal Segmental, Minimal Change Disease, Idiopathic Nephrotic Syndrome
- What is being tested?
- Biosampling
- How many people
- 500 participants
- Where
- 12 sitesGermany
- Study dates
- 1 Apr 2018to 31 Mar 2033
- How long will I take part?
- 15 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- written informed consent
- 17 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.
Who cannot join
- 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 locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
Germany12 sites, 12 recruiting
- Not yet recruiting
Uniklinik RWTH Aachen
Aachen, 52074
Claudia Seikrit, MD, cseikrit@ukaachen.de
Kerstin Schröder, keschroeder@ukaachen.de
- Recruiting
Charité University Hospital
Berlin
Jan P. Halbritter, MD, Prof., jan.halbritter@charite.de
Silke Kasbohm, + 49 30 450 514183, silke.kasbohm@charite.de
- Recruiting
Kindernierenzentrum Bonn
Bonn, 53127
Gesa Gesa, MD, +49 228 6883860, gesa.schalk@knz-bonn.de
Katja Theissen, +49 228 6883860, Katja.Theisen@knz-bonn.de
- Recruiting
University Hospital of Cologne
Cologne, North Rhine-Westphalia, 50937
paul brinkkoetter, MD, +49-221 478-4480, paul.brinkkoetter@uk-koeln.de
Lutz Weber, MD, +49 221 478-4319, lutz.weber@uk-koeln.de
- Recruiting
Kindernephrologie Dachau
Dachau, 85221
Marcus Benz, MD, +49 8131-2995954, marcus.benz@uk-koeln.de
Marcus Benz, MD
- Not yet recruiting
University Hospital Erlangen
Erlangen
Alina Hilger, MD, alina.hilger@uk-erlangen.de
Matthias Galiano, MD, Matthias.Galiano@uk-erlangen.de
- Recruiting
University Hospital Essen
Essen, 45147
Lars Pape, MD, Prof., +49 201 723 2810, lars.pape@uk-essen.de
Andreas Kribben, MD, Prof., +49 201 723 1868, nephrologie@uk-essen.de
- Recruiting
University Hospital Heidelberg
Heidelberg, 69120
Burkhard Tönshoff, MD, Prof, +49 6221 56-4002, Burkhard.Toenshoff@med.uni-heidelberg.de
Maria Luisa Möller-Winheim, +49 6221 56-310376, MariaLuisa.Moeller-Winheim@med.uni-heidelberg.de
- Recruiting
Klinikum St. Georg
Leipzig, 04129
Ralph Wendt, MD, 0341-909-4056, ralph.wendt@sanktgeorg.de
Ralph Wendt, MD
- Recruiting
University Hospital Marburg
Marburg
Stefanie Weber, MD, +49 6421-5862659, stefanie.weber@med.uni-marburg.de
Jördis Chrestensen-Fuchs, +49 6421-5864807, Joerdis.Chrestensen-Fuchs@uk-gm.de
- Recruiting
University Hospital Münster
Münster
Jens König, MD, Jens.Koenig@ukmuenster.de
Mee-Ling Maywald, MD, meeling.maywald@ukmuenster.de
- Recruiting
Klinikum Stuttgart
Stuttgart, 70174
Vedat Schwenger, Prof. MD, v.schwenger@klinikum-stuttgart.de
Castellie Cabata, c.cabata@klinikum-stuttgart.de
About this study
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.
Read the detailed 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).
- Conditions
- Glomerulosclerosis, Focal Segmental, Minimal Change Disease, Idiopathic Nephrotic Syndrome
- Being tested
- Biosampling
- Keywords
- Focal and Segmental Glomerulosclerosis, Focal & Segmental Glomerulosclerosis, FSGS, Minimal change disease, MCD, Nephrotic Syndrome
- Medical subject headings
- Glomerulosclerosis, Focal Segmental, Nephrosis, Lipoid, Macular dystrophy, corneal type 1, Nephrotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiosamplingOther
Biosampling at initial visit and follow-up visits
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Biosampling | |
| B -Adult Cohort | Adult patients 18 years and above with a biopsy-proven diagnosis of primary or secondary FSGS or MCD. Receives: Other: Biosampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Annual Change in estimated glomerular filtration rate (eGFR)
Outcome measure: eGFR loss in ml/min/year. Higher values are considered worse outcome.
Measured: 5-15 years
Incidence of End-stage Renal Disease (ESRD)
Documented initiation of chronic renal replacement therapy regardless of type.
Measured: 5-15 years
Incidence of Death
Documented patient death due to any cause
Measured: 5-15 years
Incidence of Kidney Transplantation
Documented kidney transplantation regardless of type (living donor, cadaveric donor)
Measured: 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.
Measured: 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.
Measured: 5-15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start1 Apr 2018
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glomerulosclerosis, Focal SegmentalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 15 Years
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Paul Brinkkoetter
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation, Medical Faculty and the Faculty of Natural Sciences of the University of Cologne, Cluster of Excellence on Cellular Stress Responses in Ageing-Associated Diseases, Cologne Center for Genomics
- Responsible party
- Sponsor-investigator, Prof. Dr. Paul Brinkkoetter, University of Cologne
- Investigators
- Paul T Brinkkoetter, MD, Study director, University Hospital of Cologne, Cologne, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03949972
- Sponsor's protocol ID
- 005
- Acronym
- FOrMe
- Status last verified
- Sep 2025
- First submitted
- 3 Dec 2018
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Biosamples as well as patient data will be available to collaborators after revision of research application by a steering committee.
Publications
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.
PubMed 37117201
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The FOrMe Registry (The German Focal Segmental Glomerulosclerosis and Minimal Change Disease Registry)
- ClinicalTrials.gov ID
- NCT03949972
- Acronym / sponsor ID
- FOrMe / 005
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Prof. Dr. Paul BrinkkoetterUniversity, hospital or other
- Collaborators
- German Research Foundation, Medical Faculty and the Faculty of Natural Sciences of the University of Cologne, Cluster of Excellence on Cellular Stress Responses in Ageing-Associated Diseases, Cologne Center for Genomics
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2033 (estimated)
- First posted
- 14 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A - Pediatric Cohort | – | Other: BiosamplingPediatric patients until 18 years of age presenting with or diagnosed with idiopathic nephrotic syndrome or a biopsy-proven diagnosis of MCD or FSGS. |
| B -Adult Cohort | – | Other: BiosamplingAdult patients 18 years and above with a biopsy-proven diagnosis of primary or secondary FSGS or MCD. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- written informed consent
- 17 or less years of age
- idiopathic nephrotic syndrome
- written informed consent
- older or equal to 18 years of age
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiosamplingBiosampling at initial visit and follow-up visits | Other | A - Pediatric Cohort, B -Adult Cohort |
Primary outcome
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.
Incidence of End-stage Renal Disease (ESRD)
Time frame: 5-15 years
Documented initiation of chronic renal replacement therapy regardless of type.
Incidence of Death
Time frame: 5-15 years
Documented patient death due to any cause
Incidence of Kidney Transplantation
Time frame: 5-15 years
Documented kidney transplantation regardless of type (living donor, cadaveric donor)
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Derived from this study: PubMed 37117201Osterholt 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.
- CRU 329 HomepageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Biosamples as well as patient data will be available to collaborators after revision of research application by a steering committee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul T Brinkkoetter, MD study director
University Hospital of Cologne, Cologne, Germany
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glomerulosclerosis, Focal Segmental and Minimal Change Disease, run by Prof. Dr. Paul Brinkkoetter at 12 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paul T Brinkkoetter, MD (+49-221-478-4480, paul.brinkkoetter@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Annual Change in estimated glomerular filtration rate (eGFR) (time frame: 5-15 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03949972, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.