Genetic of Chronic Kidney Disease and Gout in New Caledonia

NCT05607797 | Completed

• 1 other identifier: RC-P00116
• Study Type: interventional
• Target: 1,858
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this research is to study the associations of genetic variants of gout and kidney failure, which are very common in the Melanesian population in New Caledonia

Conditions

Gout; Renal Insufficiency, Chronic

Keywords

Gout; Renal Insufficiency Chronic; New Caledonia

Outcome Measures

Primary Outcomes (4)

• Genome-wide association study (GWAS) in gout

  GWAS is a research approach used to identify genomic variants that are statistically associated with a risk for a disease or a particular trait. The method involves surveying the genomes of many people, looking for genomic variants that occur more frequently in those with a specific disease or trait compared to those without the disease or trait. Once such genomic variants are identified, they are typically used to search for nearby variants that contribute directly to the disease or trait.

  8 months

• Phenome-wide association studies (PheWAS) in gout

  PheWAS will be used to analyze many phenotypes compared to a single genetic variant (or other attribute).

  8 months

• GWAS in CKD

  Genome-wide association study (GWAS) and Phenome-wide association studies (PheWAS) will be used. GWAS is a research approach used to identify genomic variants that are statistically associated with a risk for a disease or a particular trait. The method involves surveying the genomes of many people, looking for genomic variants that occur more frequently in those with a specific disease or trait compared to those without the disease or trait. Once such genomic variants are identified, they are typically used to search for nearby variants that contribute directly to the disease or trait. PheWAS will be used to analyze many phenotypes compared to a single genetic variant (or other attribute).

  8 months

• PheWAS in CKD

  PheWAS will be used to analyze many phenotypes compared to a single genetic variant (or other attribute).

  8 months

Secondary Outcomes (27)

• Metabolomic profile in gout

  8 months

• Metabolomic profile in CKD

  8 months

• GWAS and severity of CKD according to glomerular filtration rate (GFR)

  8 months

• GWAS and severity of gout

  8 months

• Relation between CKD and sex

  8 months

Study Arms (3)

Patients with gout

EXPERIMENTAL

Patients aged 18-70 with gout diagnosis in their medical record or claiming to have gout according to ACR/EULAR (American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria.

Other: Epidemiological study

Patients with CKD

EXPERIMENTAL

Patients aged 18-70, in dialysis or with CKD clinically diagnosed on the basis of markers of kidney damage or decreased kidney function. Patients will be recruited in dialysis centers of Wé and Maré and during the monthly nephrology consultations in medical centers.

Other: Epidemiological study

Control group

PLACEBO COMPARATOR

Persons aged 30-80 without gout or CKD. The recruitment will be done among people visiting the medical centers of Lifou and Maré for administrative or vaccination reasons.

Other: Epidemiological study

Interventions

Epidemiological study OTHER

Sociodemographic data collection, treatments collection, physical assessment, clinical examination and physical and biological measurements, biological evaluation (blood and urine samples), CKD-specific clinical features collection, gout-specific clinical features collection, clinical characteristics specific to chronic diseases, questionnaires (Health Assessment Questionnaire (HAQ-II), EuroQol (EQ)-5D-5L, joint pain, state of health, diet and physical activity, access to care, addictions, pain scale (EVA), personal and family history)

Control group; Patients with CKD; Patients with gout

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Criteria common to the 3 cohorts :
• \- Consenting to participate in the study and having signed the informed consent
• \- Claiming to be of Melanesian ethnicity
• Patients with gout :
• Age: 18 - 70 years old
• To be included in the study, a patient with a diagnosis of gout in his medical file or declaring to have gout will have to satisfy to the ACR/EULAR (ref) classification criteria :
• have had at least one episode of swelling, pain spontaneous, or triggered by pressure, of a joint peripheral or a bursa AND evidence of sodium urate crystals in a joint or bursitis symptomatic or by puncture of a tophus reported in his medical file.
• Or Score \> or =8 according to ACR/EULAR clinical criteria
• Patients with CKD
• Age: 18 - 70 years old
• Patients on dialysis or CKD clinically diagnosed on the basis of:
• Markers of kidney damage (one or more) : Albuminuria (ACR ≥ 30 mg/g), Urinary sediment abnormalities (e.g., casts urinary), Electrolyte abnormalities and other, abnormalities due to tubular disorders (eg, hyperkalemia), abnormalities detected by histology, structural abnormalities detected by imaging (e.g.,USG), history of kidney transplantation
• Decreased kidney function: GFR \< 60 ml/min/1.73 m² (calculated according to the Chronic Kidney Disease - EPIdemiology formula: CKD-EPI)
• Controls cohort
• Absence of gout or CKD

You may not qualify if:

• Pregnant women
• Individuals under guardianship / curatorship / judicially incapacitated

Sponsors & Collaborators

• Lille Catholic University: lead
• Variant Bio, Inc.: collaborator

Study Sites (1)

Medical Center of Wé (Lifou Island)

Noumea, New Caledonia

Location

MeSH Terms

Conditions

Gout; Renal Insufficiency, Chronic

Interventions

Epidemiologic Studies

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; 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

Intervention Hierarchy (Ancestors)

Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Thomas BARDIN

  Hôpital Lariboisière

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 3 groups of participants : * Patients with gout * Patients with CKD * Controls

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: November 7, 2022
• Study Start: March 14, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)