NCT04748770

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 10, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

March 16, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

February 10, 2023

Status Verified

February 1, 2023

Enrollment Period

2.9 years

First QC Date

February 9, 2021

Last Update Submit

February 9, 2023

Conditions

Kidney Transplant AccessObese PatientsDialysisComorbidities

Keywords

Kidney transplant accessobese patientsdialysiscomorbidities

Outcome Measures

Primary Outcomes (1)

  • variation of pre-transplant status two years after the obese patients' dialysis initiation between both groups

    two years

Study Arms (2)

patients with BMI≥30 kg/m2

patients with 25≤BMI≤30 kg/m2

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80480, France

RECRUITING

Central Study Contacts

Pauline Caillard, MD

CONTACT

03 22 45 58 66caillard.pauline@chu-amiens.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2021

First Posted

February 10, 2021

Study Start

March 16, 2021

Primary Completion

February 1, 2024

Study Completion

February 1, 2025

Last Updated

February 10, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)