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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07288723
Acronym
APOL1
Enrollment
88
Registered
2025-12-17
Start date
2023-04-06
Completion date
2025-04-06
Last updated
2025-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Diseases

Keywords

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

Brief summary

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

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.

Interventions

None listed

Sponsors

Centre Hospitalier Universitaire de la Guadeloupe
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Frequency of alleles (G1 and G2) of APOL1At baseline (study inclusion).The frequency of APOL1 risk alleles (G1 and G2 variants) will be determined in patients with stage 4 chronic kidney disease (CKD). This measure aims to describe the distribution of APOL1 genotypes within the study population and to identify the proportion of participants carrying one or two risk alleles, which may inform the analysis of associations with clinical and biochemical outcomes. Genotyping of APOL1 variants using DNA extracted from EDTA blood samples, analyzed by validated molecular biology techniques.

Secondary

MeasureTime frameDescription
Prevalence of HypertensionAt baseline (study inclusion)Percentage of participants with hypertension, defined according to ESC/ESH clinical criteria Unit of Measure: Percentage of participants Measurement Method: Standardized blood pressure measurement and/or current antihypertensive treatment
Prevalence of MalnutritionAt baseline (study inclusion)Percentage of participants meeting GLIM criteria for malnutrition Unit of Measure: Percentage of participants Measurement Method: BMI, serum albumin, weight loss history, clinical nutritional assessment
Echocardiographic AbnormalitiesAt baseline (study inclusion)Number of participants with at least one structural or functional cardiac abnormality (e.g., left ventricular hypertrophy, systolic or diastolic dysfunction) Unit of Measure: Number of participants Measurement Method: Standard transthoracic echocardiography (LVEF, E/e', wall thickness…)
Prevalence of DiabetesAt baseline (study inclusion)Percentage of participants with diabetes, defined according to ADA diagnostic criteria Measurement Method: Fasting glucose, HbA1c, and/or current antidiabetic treatment
Plasma NT-proBNP concentration (pg/mL)At baseline (study inclusion).Plasma concentration of N-terminal pro-B-type natriuretic peptide (NT-proBNP) measured by a validated immunoassay on blood samples collected at study inclusion. Higher NT-proBNP values reflect greater cardiac stress / volume overload. Results will be reported as continuous values (pg/mL) and summary statistics (mean, median, SD, IQR). Unit of Measure: pg/mL
Plasma Concentration of FGF-23At baseline (study inclusion)Plasma levels of Fibroblast Growth Factor-23 (FGF-23) will be measured in patients with stage 4 chronic kidney disease (CKD). The objective is to evaluate the association between circulating FGF-23 concentrations and APOL1 risk alleles (G1 and G2 variants), as well as to explore their potential relationships with cardiovascular and renal complications. FGF-23 concentrations will be quantified in plasma samples stored in the biobank using a validated immunoassay.
Presence of Vascular CalcificationsAt baseline (study inclusion)Percentage of participants with vascular calcifications detected on imaging. Unit of Measure: Percentage of participants Measurement Method: Imaging-based assessment (e.g., arterial calcium score according to clinical practice)

Countries

Guadeloupe

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026