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GoutCALEDGOUTCKDNCT05607797

Genetic of Chronic Kidney Disease and Gout in New Caledonia

A study testing Epidemiological study in people with Gout and Renal Insufficiency, Chronic, run by Lille Catholic University at 1 site in New Caledonia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Gout, Renal Insufficiency, Chronic
What is being tested?
Epidemiological study
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,858 participants
Where
1 siteNew Caledonia
Study dates
14 Mar 2023to 30 Apr 2024
Phase
Interventional
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 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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 :
Show all 16Show fewer
  • 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
  • Age: 30 - 80 years old

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

New Caledonia1 site

  • Medical Center of Wé (Lifou Island)

    Noumea

About this study

Official title: Genetic of Chronic Kidney Disease and Gout : Analysis of Melanesian Families From New Caledonia

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

Read the detailed description

Gout is a chronic pathology linked to the deposition in the tissues of monosodium urate (MSU) crystals, secondary to hyperuricemia (high blood levels of urate). Gout causes very painful joint attacks that are first acute and then lead to chronic pain, and disabling deforming manifestations called tophus. The disease is strongly associated with cardiovascular comorbidities and chronic renal failure.

In New Caledonia, the prevalence of chronic kidney disease (CKD) (according to the glomerular filtration rate (GFR) < 60 ml/min) was of 7.4% in 2015 (according to the epidemiological study "Barometer Health 2015"). In the Loyalty Islands, which has overall significantly more Melanesian population, a local database showed that in 2018 the prevalence of patients having at least one blood test reporting kidney disease (GFR CKD< 60 ml/min) and seen at least once in the previous two years was as follows:

  • 7.7% in Lifou (9,200 inhabitants)
  • 8.4% in Maré (5,700 inhabitants)
  • 9.1% in Ouvéa (3,400 inhabitants) In summary, inflammatory diseases such as CKD and gout have high prevalence in New Caledonia and the Loyalty Islands, and constitute a major health issue. Although the high prevalence of these diseases is probably due in part to non-genetic factors (environment, diet, etc.), it is likely, given the demographic history of this region, that undetected genetic risk alleles among the Melanesian population contribute to the appearance and progression of diseases. Performing genetic and epidemiological studies in an as yet understudied region is essential to identify these variants, which could lead to improved diagnoses and health outcomes.
Being tested
Epidemiological study
Keywords
Gout, Renal Insufficiency Chronic, New Caledonia
Medical subject headings
Gout, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Epidemiological studyOther

    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)

Study groups in NCT05607797
Study groupRoleWhat they receive
Patients with goutExperimentalPatients 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.
Receives: Other: Epidemiological study
Patients with CKDExperimentalPatients 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.
Receives: Other: Epidemiological study
Control groupPlacebo comparatorPersons 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.
Receives: Other: Epidemiological study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 8 months

  2. Phenome-wide association studies (PheWAS) in gout

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

    Measured: 8 months

  3. 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).

    Measured: 8 months

  4. PheWAS in CKD

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

    Measured: 8 months

Secondary outcomes (27)

  1. Metabolomic profile in gout

    Metabolomics profiling will be conducted using ultrahigh-performance liquid chromatography-tandem mass-spectrometry by the metabolomics provider Metabolon Inc. (USA) on fasting serum samples from participants. The metabolomic dataset measured by Metabolon includes known metabolites containing the following broad categories - amino-acids, peptides, carbohydrates, energy intermediates, lipids, nucleotides, cofactors and vitamins, and xenobiotics.

    Measured: 8 months

  2. Metabolomic profile in CKD

    Metabolomics profiling will be conducted using ultrahigh-performance liquid chromatography-tandem mass-spectrometry by the metabolomics provider Metabolon Inc. ( USA) on fasting serum samples from participants. The metabolomic dataset measured by Metabolon includes known metabolites containing the following broad categories - amino-acids, peptides, carbohydrates, energy intermediates, lipids, nucleotides, cofactors and vitamins, and xenobiotics.

    Measured: 8 months

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

    GWAS will be used to identify genomic variants that are statistically associated with severity. Stage of severity according to GFR (mL/min/1.73m2):

    1. Mild renal impairment with normal or increased filtration : Over 90
    2. Mild decrease in renal function : 60-89
    3. Moderate decrease in renal function : 30-59
    4. Severe decrease in renal function : 15-29
    5. Renal failure: Less than 15 (or dialysis)

    Measured: 8 months

  4. GWAS and severity of gout

    GWAS will be used to identify genomic variants that are statistically associated with severity.

    Severity will be defined using four binary variables: number of attacks (cutoff six attacks per year), presence of clinical tophus (yes or no), uric acid level (>80 mg/L or 480 micromol/L) and age of onset (<30 years) .

    Measured: 8 months

  5. Relation between CKD and sex

    Relation between CKD and sex (Male/ Female)

    Measured: 8 months

  6. Relation between gout and sex

    Relation between gout and sex (Male/ Female)

    Measured: 8 months

  7. Relation between CKD and age

    Relation between CKD and age

    Measured: 8 months

  8. Relation between gout and age

    Relation between gout and age

    Measured: 8 months

  9. Relation between CKD and Body Mass Index (BMI)

    Relation between CKD and Body Mass Index (BMI) in kg/m^2

    Measured: 8 months

  10. Link between gout and Body Mass Index (BMI)

    Link between gout and Body Mass Index (BMI) in kg/m^2

    Measured: 8 months

  11. Relation between CKD and the Body Fat Percentage

    Relation between CKD and the Body Fat Percentage in Percentage (%)

    Measured: 8 months

  12. Relation between gout and the Body Fat Percentage

    Relation between gout and the Body Fat Percentage in Percentage (%)

    Measured: 8 months

  13. Relation between CKD and Muscle Mass Percentage

    Relation between CKD and Muscle Mass Percentage in Percentage (%)

    Measured: 8 months

  14. Relation between gout and Muscle Mass Percentage

    Relation between gout and Muscle Mass Percentage in Percentage (%)

    Measured: 8 months

  15. Relation between CKD and Basal Metabolism

    Relation between CKD and Basal Metabolism in Joules

    Measured: 8 months

  16. Relation between gout and Basal Metabolism

    Relation between gout and Basal Metabolism in Joules

    Measured: 8 months

  17. Relation between CKD and Visceral Fat Percentage

    Relation between CKD and Visceral Fat Percentage in Percentage

    Measured: 8 months

  18. Relation between gout and Visceral Fat Percentage

    Relation between gout and Visceral Fat Percentage in Percentage

    Measured: 8 months

  19. Relation between CKD and height

    Relation between CKD and height in meters

    Measured: 8 months

  20. Relation between gout and height

    Relation between gout and height in centimeters

    Measured: 8 months

  21. Relation between CKD and waist size

    Relation between CKD and waist size in centimeters

    Measured: 8 months

  22. Relation between gout and waist size

    Relationbetween gout and waist size in centimeters

    Measured: 8 months

  23. Relation between CKD and hip circumference

    Relation between CKD and hip circumference in centimeters

    Measured: 8 months

  24. Relation between gout and hip circumference

    Relation between gout and hip circumference in centimeters

    Measured: 8 months

  25. Relation between CKD and waist/hip ratio

    Relation between CKD and waist/hip ratio

    Measured: 8 months

  26. Relation between gout and waist/hip ratio

    Relation between gout and waist/hip ratio

    Measured: 8 months

  27. Mendelian randomization

    Mendelian randomization uses measured variation in genes to interrogate the causal effect of an exposure on comorbidities development

    Measured: 8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2022
  2. Study start14 Mar 2023
  3. Primary completion30 Apr 2024
  4. Study completion30 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
3 groups of participants : * Patients with gout * Patients with CKD * Controls
Masking
None (open label)
Enrolment
1,858 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05607797
Sponsor's protocol ID
RC-P00116
Acronym
CALEDGOUTCKD
Status last verified
Nov 2024
First submitted
18 Oct 2022
Last updated
27 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Epidemiological study in people with Gout and Renal Insufficiency, Chronic, run by Lille Catholic University at 1 site in New Caledonia.

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 16 inclusion and 2 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 27 Nov 2024. 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 New Caledonia. 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. Some participants in this study may receive a placebo. 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?

Genome-wide association study (GWAS) in gout (time frame: 8 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05607797.

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 27 Nov 2024.

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