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

NCT07288723 | Completed

• 1 other identifier: PAP_RNI_2018/03
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Kidney Diseases

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  At baseline (study inclusion).

Secondary Outcomes (7)

• Prevalence of Diabetes

  At baseline (study inclusion)

• Prevalence of Hypertension

  At baseline (study inclusion)

• Prevalence of Malnutrition

  At baseline (study inclusion)

• Echocardiographic Abnormalities

  At baseline (study inclusion)

• Presence of Vascular Calcifications

  At baseline (study inclusion)

Study Arms (1)

Case

Patients with stage 4 of chronic kidney disease (CKD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Guadeloupe: lead

Study Sites (1)

CHU de la Guadeloupe

Pointe-à-Pitre, 97159, Guadeloupe

Location

Biospecimen

Retention: SAMPLES WITH DNA

A plasma bank, which will be used for the measurement of FGF-23 and DNA bank, which will be used for genotyping of APOL1 gene polymorphisms.

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Befa NOTO-KADOU-KAZA, MD

  CHU de la Guadeloupe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 17, 2025
• Study Start: April 6, 2023
• Primary Completion: April 6, 2025
• Study Completion: April 6, 2025
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

GU (1)