Major Activation Of NCC in Graft Urinary Exosomes

NCT ID: NCT03503461

Last Updated: 2018-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

67 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-21

Study Completion Date

2018-08-31

Brief Summary

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Hypertension is common disorder after renal transplantation and is associated with mortality. Calcineurin Inhibitor (CNI), by activating NCC cotransporter, may be a major determinant of hypertension, included in a "Gordon like" syndrome. However, prevalence of NCC activation by CNI is unknown. Our objective is to determine the prevalence of NCC activation three months after transplantation in patient treated by CNI.

Detailed Description

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Hypertension is common disorder after renal transplantation and is associated with mortality. Calcineurin Inhibitor (CNI), by activating NCC cotransporter, may be a major determinant of hypertension, included in a "Gordon like" syndrome. Gordon syndrome is a rare genetic disorder where NCC cotransporter is overactivated and cause hypertension, metabolic acidosis and tendency to hyperkaliemia. Few studies evaluated NCC expression by exosomes techniques in human kidney transplant, and mostly compared NCC expression in specific subpopulation (for example with or without hypertension). Thus, prevalence of NCC activation by CNI is unknown. To determine it, we will include prospective patients in Bordeaux and la Réunion who undergo urine and blood tests three months after transplantation, and a control group with no transplantation and no use of CNI. First, we will compare kidney recipients and control and use immunoblot to quantify NCC expression in urinary exosomes to identify the population of transplanted with a high activation. Then, we will analyze the relationship between NCC activation and clinicobiological features of Gordon's syndrome.

Conditions

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Kidney Transplantation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Control group

Control group is a population of subjects admitted to day hospitalization for renal function tests or in conventional hospitalization, but without kidney transplant. Exosome analysis will be perform in urine sample.

exosomes analysis

Intervention Type OTHER

Perform exosomes analysis in urine sample obtain from usual urine testing in both kidney transplant and control group.

Kidney transplants group

Kidney transplants group is a kidney transplant subjects population 3 months ago. Exosome analysis will be perform in urine sample collected at 3 months.

exosomes analysis

Intervention Type OTHER

Perform exosomes analysis in urine sample obtain from usual urine testing in both kidney transplant and control group.

Interventions

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exosomes analysis

Perform exosomes analysis in urine sample obtain from usual urine testing in both kidney transplant and control group.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age≥18years
* Recipients three months after kidney transplantation using calcineurin inhibitors
* Glomerular Filtration Rate\>15ml.mn.m2 CKD-EPI
* Renal ultrasound underwent before inclusion
* No opposition at participating at the research

* No previous transplantation
* Age≥18years
* No hypertension
* No metabolic disorders (dysnatremia, dyskaliemia, acidosis or alkalosis)
* No opposition at participating at the research

Exclusion Criteria

* Use of diuretic thiazides or aldosterone receptor antagonists in the month preceding inclusion
* Graft artery stenosis with indication of interventional radiology or surgery

For control group :


* Use of diuretic thiazides or aldosterone receptor antagonists in the month preceding inclusion
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hopital Pellegrin - Service Néphrologie, transplantation, dialyse et aphérèse

Bordeaux, , France

Site Status

Hopital Felix Guyon - Service d'Explorations Fonctionnelles Rénales

Saint-Denis, , Reunion

Site Status

Countries

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France Reunion

Other Identifiers

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CHUBX 2018/08

Identifier Type: -

Identifier Source: org_study_id

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