Clinical Trial on Chronic Kidney Diseases - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Chronic Kidney Diseases

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.

Study Type

Observational

Enrollment (Actual)

88

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Guadeloupe
- - Pointe-à-Pitre, Guadeloupe, 97159
    - CHU de la Guadeloupe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of adult patients (≥18 years) with stage 4 chronic kidney disease (CKD), defined by a glomerular filtration rate (GFR) between 15 and 29 mL/min/1.73 m², patients are afro-caribeans and living i Guadeloupe. Participants will be recruited from a unique center (University Center Hospital of Guadeloupe) involved in the study.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Case Patients with stage 4 of chronic kidney disease (CKD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At baseline (study inclusion).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At baseline (study inclusion)
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	At baseline (study inclusion)
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	At baseline (study inclusion)
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…)	At baseline (study inclusion)
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)	At baseline (study inclusion)
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	At baseline (study inclusion).
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.	At baseline (study inclusion)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de la Guadeloupe

Investigators

Principal Investigator: Befa NOTO-KADOU-KAZA, MD, CHU de la Guadeloupe

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 6, 2023

Primary Completion (Actual)

April 6, 2025

Study Completion (Actual)

April 6, 2025

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

December 3, 2025

First Posted (Actual)

December 17, 2025

Study Record Updates

Last Update Posted (Actual)