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

February 9, 2023 updated by: Centre Hospitalier Universitaire, Amiens
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

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80480
        • Recruiting
        • CHU Amiens
        • Sub-Investigator:
          • Gabriel Choukroun, PR
        • Sub-Investigator:
          • Pierre-François Westeel, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: two years
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 16, 2021

Primary Completion (ANTICIPATED)

February 1, 2024

Study Completion (ANTICIPATED)

February 1, 2025

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)

February 10, 2023

Last Update Submitted That Met QC Criteria

February 9, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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