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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04748770
Recruitment Status : Recruiting
First Posted : February 10, 2021
Last Update Posted : March 18, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Study Description
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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.

Condition or disease
Kidney Transplant Access Obese Patients Dialysis Comorbidities

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Access to Kidney Transplant of Obese Patients Beginning Dialysis
Actual Study Start Date : March 16, 2021
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : February 2025

Resource links provided by the National Library of Medicine


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


Outcome Measures
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Primary Outcome Measures :
  1. variation of pre-transplant status two years after the obese patients' dialysis initiation between both groups [ Time Frame: two years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04748770


Contacts
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Contact: Pauline Caillard, MD 03 22 45 58 66 caillard.pauline@chu-amiens.fr

Locations
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France
CHU Amiens Recruiting
Amiens, France, 80480
Contact: Pauline Caillard, MD    03 22 45 58 66    caillard.pauline@chu-amiens.fr   
Sub-Investigator: Gabriel Choukroun, PR         
Sub-Investigator: Pierre-François Westeel, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
More Information
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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT04748770    
Other Study ID Numbers: PI2021_843_0016
First Posted: February 10, 2021    Key Record Dates
Last Update Posted: March 18, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire, Amiens:
Kidney transplant access
obese patients
dialysis
comorbidities
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight