Access to Kidney Transplant of Obese Patients Beginning Dialysis (Transplantob)

Obesity is in constant increase all over the world and affects 35% of the global population according to the World Health Organisation. It is associated with other cardiovascular risk factors (particularly hypertension and diabetes) and with high morbi-mortality. It is also responsible for an increase of the risk of developing chronic kidney diseases (CKD). In fact, obese patients represent 25% of the dialysis population and Picardy is one of the most affected areas. However, their access to kidney transplant is still restricted and the reasons are not completely understood.

Study Overview

• Status: Recruiting
• Conditions: Dialysis; Comorbidities; Obese Patients; Kidney Transplant Access

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Pauline Caillard, MD; Phone Number: 03 22 45 58 66; Email: caillard.pauline@chu-amiens.fr

Study Locations

• France
  • Amiens, France, 80480
    • Recruiting
    • Chu Amiens
    • Sub-Investigator: Gabriel Choukroun, PR
    • Sub-Investigator: Pierre-François Westeel, MD
    • Contact: Pauline Caillard, MD; Phone Number: 03 22 45 58 66; Email: caillard.pauline@chu-amiens.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients will be included in the study one month after the dialysis initiation. All clinical (obesity history, comorbidities, nephropathy aetiology and treatment…) and biological (nutrition markers, hemoglobin, brain natriuretic peptide (BNP)…) informations after one month and during the two years of follow-up (weight evolution, obesity complications, transplant path...) will be collected.

Description

Inclusion Criteria:

• Age over 18 years old.
• Patients with BMI≥30 kg/m2 (for study population) and 25≤BMI≤30 kg/m2(for control population) one month after dialysis initiation.
• Patients agree with their data collection.

Exclusion Criteria:

• Patients with bariatric surgery history.
• Patients needed dialysis for graft dysfunction.
• Data loss.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
patients with BMI≥30 kg/m2
patients with 25≤BMI≤30 kg/m2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
variation of pre-transplant status two years after the obese patients' dialysis initiation between both groups	two years

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: February 9, 2021
• First Submitted That Met QC Criteria: February 9, 2021
• First Posted (Actual): February 10, 2021

Study Record Updates

• Last Update Posted (Actual): June 15, 2026
• Last Update Submitted That Met QC Criteria: June 12, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: comorbidities; dialysis; obese patients; Kidney transplant access
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: PI2021_843_0016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No