Chronic Kidney DiseasesAPOL1NCT07288723
Chronic Kidney Disease : Role of Biological Factors and Apolipoprotein L1 Encoding Gene (APOL1)
An observational study of Chronic Kidney Diseases, run by Centre Hospitalier Universitaire de la Guadeloupe at 1 site in Guadeloupe.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Diseases
- How many people
- 88 participants
- Where
- 1 siteGuadeloupe
- Study dates
- 6 Apr 2023to 6 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chronic Kidney Disease : Role of Biological Factors and Apolipoprotein L1 Encoding Gene
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).
Read the 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.
- Conditions
- Chronic Kidney Diseases
- Keywords
- chronic kidney disease, stage renal disease, NT-ProBNP, FGF-23, APOL1 genetic variants
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case | Patients with stage 4 of chronic kidney disease (CKD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of alleles (G1 and G2) of APOL1
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.
Measured: At baseline (study inclusion).
Secondary outcomes (7)
Prevalence of Diabetes
Percentage of participants with diabetes, defined according to ADA diagnostic criteria Measurement Method: Fasting glucose, HbA1c, and/or current antidiabetic treatment
Measured: At baseline (study inclusion)
Prevalence of Hypertension
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
Measured: At baseline (study inclusion)
Prevalence of Malnutrition
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
Measured: At baseline (study inclusion)
Echocardiographic Abnormalities
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…)
Measured: At baseline (study inclusion)
Presence of Vascular Calcifications
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)
Measured: At baseline (study inclusion)
Plasma NT-proBNP concentration (pg/mL)
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
Measured: At baseline (study inclusion).
Plasma Concentration of FGF-23
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.
Measured: At baseline (study inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start6 Apr 2023
- Primary completion6 Apr 2025
- Study completion6 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Guadeloupe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Befa NOTO-KADOU-KAZA, MD, Principal investigator, CHU de la Guadeloupe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07288723
- Sponsor's protocol ID
- PAP_RNI_2018/03
- Acronym
- APOL1
- Status last verified
- Dec 2025
- First submitted
- 14 Nov 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Kidney Disease : Role of Biological Factors and Apolipoprotein L1 Encoding Gene
- ClinicalTrials.gov ID
- NCT07288723
- Acronym / sponsor ID
- APOL1 / PAP_RNI_2018/03
- Conditions
- Chronic Kidney Diseases
- Keywords
- chronic kidney disease, stage renal disease, NT-ProBNP, FGF-23, APOL1 genetic variants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la GuadeloupeUniversity, hospital or other
- Study start
- 6 Apr 2023 (actual)
- Primary completion
- 6 Apr 2025 (actual)
- Study completion
- 6 Apr 2025 (actual)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Case | – | –Patients with stage 4 of chronic kidney disease (CKD) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
7 secondary outcomes
Prevalence of Diabetes
Time frame: At baseline (study inclusion)
Prevalence of Hypertension
Time frame: At baseline (study inclusion)
Prevalence of Malnutrition
Time frame: At baseline (study inclusion)
Echocardiographic Abnormalities
Time frame: At baseline (study inclusion)
Presence of Vascular Calcifications
Time frame: At baseline (study inclusion)
Plasma NT-proBNP concentration (pg/mL)
Time frame: At baseline (study inclusion).
Plasma Concentration of FGF-23
Time frame: At baseline (study inclusion)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Befa NOTO-KADOU-KAZA, MD principal investigator
CHU de la Guadeloupe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases, run by Centre Hospitalier Universitaire de la Guadeloupe at 1 site in Guadeloupe.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guadeloupe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of alleles (G1 and G2) of APOL1 (time frame: At baseline (study inclusion).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.