NCT03949972 The FOrMe Registry (The German Focal Segmental Glomerulosclerosis and Minimal Change Disease Registry)
| NCT ID | NCT03949972 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Prof. Dr. Paul Brinkkoetter |
| Condition | Glomerulosclerosis, Focal Segmental |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2018-04-01 |
| Primary Completion | 2028-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2018-04-01 with a primary completion date of 2028-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Paul T Brinkkoetter, MD
STUDY DIRECTOR
University Hospital of Cologne, Cologne, Germany
Frequently Asked Questions
Who can join the NCT03949972 clinical trial?
This trial is open to participants of all sexes, studying Glomerulosclerosis, Focal Segmental. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03949972 currently recruiting?
Yes, NCT03949972 is actively recruiting participants. Contact the research team at paul.brinkkoetter@uk-koeln.de for enrollment information.
Where is the NCT03949972 trial being conducted?
This trial is being conducted at Cologne, Germany, Aachen, Germany, Berlin, Germany, Bonn, Germany and 8 additional locations.
Who is sponsoring the NCT03949972 clinical trial?
NCT03949972 is sponsored by Prof. Dr. Paul Brinkkoetter. The principal investigator is Paul T Brinkkoetter, MD at University Hospital of Cologne, Cologne, Germany. The trial plans to enroll 500 participants.