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NCT Number: NCT07288723

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

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Frequency of alleles (G1 and G2) of APOL1

    Time frame: At 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 outcomes

  1. Prevalence of Diabetes

    Time frame: At baseline (study inclusion)

    Percentage of participants with diabetes, defined according to ADA diagnostic criteria Measurement Method: Fasting glucose, HbA1c, and/or current antidiabetic treatment

  2. Prevalence of Hypertension

    Time frame: At 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

  3. Prevalence of Malnutrition

    Time frame: At 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

  4. Echocardiographic Abnormalities

    Time frame: At 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…)

  5. Presence of Vascular Calcifications

    Time frame: At 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)

  6. Plasma NT-proBNP concentration (pg/mL)

    Time frame: 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

  7. Plasma Concentration of FGF-23

    Time frame: At 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de la Guadeloupe

Other

Registry information

Official study title

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

Acronym: APOL1

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 17, 2025
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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