Chronic Kidney Disease : Role of Biological Factors and Apolipoprotein L1 Encoding Gene (APOL1)

NCT ID: NCT07288723

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

88 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-06

Study Completion Date

2025-04-06

Brief Summary

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Chronic kidney disease (CKD) is a major global public health issue. The present project focuses on the role of apolipoprotein L1 (APOL1) in patients with stage 4 CKD (glomerular filtration rate between 15 and 29 mL/min/1.73 m²).

Detailed Description

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Chronic kidney disease (CKD) is a worldwide public health problem. The project concerns the apolopoprotein L1 at stage 4 of severe chronic kidney disease (defined by a glomerular filtration rate of 29-15 ml / min / 1.73 m2).

Traditional risk factors (diabetes, cardiovascular diseases) and non-traditional such as inflammation and malnutrition are prognostic factors of mortality in our population.

Other parameters, less frequently described, would predict complications and mortality in patients on dialysis and in pre-dialysis the Fibroblast growth factor-23 (FGF-23) that regulates phosphates metabolism (Pereira, Juppner et al. 2009) and the " N terminal fragment of brain natriuretic peptide" (NT-proBNP), which plays a major role in regulation of blood pressure and extracellular volume.

Studies have suggested that black populations (African Americans) have a more rapid decline in kidney function than whites (European Americains).

The role of two variants (G1 and G2) of the gene encoding apolipoprotein L1 (APOL1) was mentioned. These APOL1 variants are common in African Americans (more than 50% are carriers of at least one risk allele). Carriers of 2 risk alleles would present a more rapid progression to end stage and, high-risk genotypes would explain most of the excess CKD risk for people of African descent. These variants of APOL1 Chronic kidney disease (CKD) is a worldwide public health problem. Our project concerns the apolopoprotein L1 at stage 4 of severe chronic kidney disease (defined by a glomerular filtration rate of 29-15 ml / min / 1.73 m2).

Traditional risk factors (diabetes, cardiovascular diseases) and non-traditional such as inflammation and malnutrition are prognostic factors of mortality in caribean population.

Other parameters, less frequently described, would predict complications and mortality in patients on dialysis and in pre-dialysis the Fibroblast growth factor-23 (FGF-23) that regulates phosphates metabolism and the " N terminal fragment of brain natriuretic peptide" (NT-proBNP), which plays a major role in regulation of blood pressure and extracellular volume.

Studies have suggested that black populations (African Americans) have a more rapid decline in kidney function than whites (European Americains). The role of two variants (G1 and G2) of the gene encoding apolipoprotein L1 (APOL1) was mentioned. These APOL1 variants are common in African Americans (more than 50% are carriers of at least one risk allele). Carriers of 2 risk alleles would present a more rapid progression to end stage and, high-risk genotypes would explain most of the excess CKD risk for people of African descent. These variants of APOL1 would also be associated with atherosclerotic cardiovascular disease.

Conditions

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Chronic Kidney Diseases

Keywords

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chronic kidney disease stage renal disease NT-ProBNP FGF-23 APOL1 genetic variants

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Case

Patients with stage 4 of chronic kidney disease (CKD)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients 18 y and older, of both sexes, Afro Caribbeans
* Living in Guadeloupe
* Having been informed of objectives and constraints of the study and who have given their written consent.
* For patients with CKD : at stage 4 (GFR \< than 30 ml / min / 1.73m2.), whatever the etiology of CKD, associated pathologies and treatments,
* For patients with normal renal function : serum creatinine \< 10 mg/l.

Exclusion Criteria

* Patients 18 y and older, of both sexes, Afro Caribbeans
* Living in Guadeloupe
* Having been informed of objectives and constraints of the study and who have given their written consent.
* For patients with CKD : at stage 4 (GFR \< than 30 ml / min / 1.73m2.), whatever the etiology of CKD, associated pathologies and treatments,
* For patients with normal renal function : serum creatinine \< 10 mg/l.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire de la Guadeloupe

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Befa NOTO-KADOU-KAZA, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de la Guadeloupe

Locations

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CHU de la Guadeloupe

Pointe-à-Pitre, , Guadeloupe

Site Status

Countries

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Guadeloupe

Other Identifiers

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PAP_RNI_2018/03

Identifier Type: -

Identifier Source: org_study_id