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

NCT06443034 | Not Yet Recruiting

• 1 other identifier: APHP240269
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicentric retrospective observational cohort study. As primary objective, the study aims to evaluate the factors associated with nephrotic syndrome remission in patient with nephrotic syndrome, biopsy-prove minimal change disease or focal segmental glomerulosclerosis, and an at-risk variant of the APOL1 gene. As secondary objectives, this study aims:

• To evaluate the benefit of corticosteroids in obtaining the remission of nephrotic syndrome
• To identify the predictors of complete renal remission of nephrotic syndrome
• To evaluate the benefit of corticosteroids in reducing the incidence of end-stage renal disease
• To assess the adverse events of corticosteroids in patients treated with corticosteroids.

Conditions

Nephrotic Syndrome; Focal Segmental Glomerulosclerosis; APOL1 Associated Kidney Disease

Keywords

Nephrotic syndrome; Covid-19 associated nephropathy; human immunodeficiency virus associated nephropathy; APOL1 associated kidney disease; Focal segmental glomerulosclerosis; Minimal change disease

Outcome Measures

Primary Outcomes (1)

• nephrotic syndrome remission

  Description: remission of nephrotic syndrome is defined as a complete or partial remission of nephrotic syndrome as follows: * Complete remission: * Urine protein / creatinine ratio \< 0.3 g/g AND * Albuminemia \> 35 g/L * Partial remission: * Urine protein / creatinine ratio \> 0.3 g/g AND * Urine protein / creatinine ratio \< 3.5 g/g AND * \> 50% reduction of urine protein / creatinine ratio from baseline (at the time of biopsy)

  up to 12 months

Secondary Outcomes (3)

• end stage renal disease

  up to 12 months

• complete remission of nephrotic syndrome Time Frame : between kidney biopsy and last follow-up

  up to 12 months

• adverse effects of corticosteroids

  up to 12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients APOL1 gene status will be obtained from the Hôpital Européen Georges Pompidou genetic laboratory (performing all APOL1 gene analysis in Paris greater area). Patients with a biopsy-proven focal segmental glomerulosclerosis or minimal change disease and nephrotic syndrome will be screened in each center.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Néphrologie & Dialyses department, Tenon Hospital

Paris, 75020, France

Location

MeSH Terms

Conditions

Nephrotic Syndrome; Glomerulosclerosis, Focal Segmental; AIDS-Associated Nephropathy; Nephrosis, Lipoid

Condition Hierarchy (Ancestors)

Nephrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Glomerulonephritis; Nephritis; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Central Study Contacts

Romain Brousse, MD, PhD

CONTACT

+33156017043; Romain.brousse@aphp.fr

Boffa Jean-Jacques, MD, PhD

CONTACT

+33156016029; Jean-jacques.boffa@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 5, 2024
• Study Start: June 30, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: June 5, 2024

Record last verified: 2024-06

Locations

FR (1)