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Search / Trial NCT06443034

Predictive Determinants of Nephrotic Syndrome Remission in Patients With At-risk Polymorphism of APOL1

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Jun 3, 2024

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Nephrotic Syndrome Covid 19 Associated Nephropathy Human Immunodeficiency Virus Associated Nephropathy Apol1 Associated Kidney Disease Focal Segmental Glomerulosclerosis Minimal Change Disease

ClinConnect Summary

This clinical trial is focused on understanding what factors might help patients with nephrotic syndrome—specifically those with a certain genetic risk factor called the APOL1 variant—achieve remission, which means their symptoms improve or disappear. The study will look at patients who have been diagnosed with two specific types of kidney damage, called minimal change disease or focal segmental glomerulosclerosis. Researchers will also explore how well corticosteroids, a type of medication, work in helping patients recover and whether these medications have any side effects.

To be eligible for this study, participants must be adults who have been treated in one of six nephrology centers between January 2016 and June 2024. They need to have a certain level of protein and a specific condition called hypoalbuminemia (low albumin levels in the blood) at the time of their kidney diagnosis. It's important to note that individuals with certain other kidney conditions or who do not wish to have their medical data used in research will not be included. While the trial is not yet recruiting participants, those who qualify will help researchers gather valuable information to improve treatment for nephrotic syndrome.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Adult patients followed in 6 nephrology centers between 01/01/2016 and 01/06/2024.
  • With characterization of APOL1 gene risk status
  • Proteinuria/creatinuria ratio \> 3 g/g at diagnosis of renal disease (within 48 hours of the diagnostic renal biopsy)
  • Hypoalbuminemia \< 30 g/L at diagnosis of renal disease (within 48 h of diagnostic renal biopsy)
  • Minimal change disease or segmental and focal hyalinosis lesions on renal biopsy.
  • Exclusion Criteria:
  • Presence of diffuse deposits of immunoglobulins or complement fractions on immunofluorescence study
  • Presence of endo- or extracapillary hypercellular lesions on light microscopy
  • Opposition to the use of medical data

About Assistance Publique Hôpitaux De Paris

Assistance Publique - Hôpitaux de Paris (AP-HP) is a leading public hospital system in France, renowned for its commitment to healthcare excellence and innovative medical research. As a prominent clinical trial sponsor, AP-HP plays a pivotal role in advancing medical knowledge and improving patient care through rigorous scientific investigations across a wide range of therapeutic areas. With a focus on collaboration and interdisciplinary approaches, AP-HP leverages its extensive network of hospitals and expert clinicians to facilitate high-quality clinical trials that adhere to the highest ethical and regulatory standards, ultimately aiming to translate research findings into tangible health benefits for diverse patient populations.

Locations

Paris, , France

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported