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Major Activation Of NCC in Graft Urinary Exosomes (MANGUE)

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ClinicalTrials.gov Identifier: NCT03503461
Recruitment Status : Completed
First Posted : April 19, 2018
Last Update Posted : November 14, 2018
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief Summary:
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.

Condition or disease Intervention/treatment
Kidney Transplantation Other: exosomes analysis

Detailed Description:
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.

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Study Type : Observational
Actual Enrollment : 67 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation of the Prevalence of an Hyperactivation of NCC Cotransporter Three Months After Kidney Transplantation in Recipients Treated by Calcineurin Inhibitors
Actual Study Start Date : June 21, 2018
Actual Primary Completion Date : August 31, 2018
Actual Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Other: exosomes analysis
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.
Other: exosomes analysis
Perform exosomes analysis in urine sample obtain from usual urine testing in both kidney transplant and control group.




Primary Outcome Measures :
  1. NCC cotransporter expression [ Time Frame: Inclusion day ]
    Dosage of NCC cotransporter expression in urinary exosomes samples in both groups.


Secondary Outcome Measures :
  1. Phosphorylated NCC cotransporter expression [ Time Frame: Inclusion day ]
    Dosage of phosphorylated NCC cotransporter expression in urinary exosomes samples in both groups.

  2. pendrine expression in kidney transplant group [ Time Frame: Inclusion day ]
    Dosage of pendrine expression in urinary exosomes samples in kidney transplant group.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Kidney transplant group is a population of transplant subjects treated with anticalcineurin since 3 months.

Control group is a population of subjects admitted to day hospitalization for renal function tests or in conventional hospitalization, but without kidney transplant.

Criteria

For kidney transplant group :

  • 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
  • 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 :

  • Inclusion criteria

    • 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

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): NCT03503461


Locations
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France
Hopital Pellegrin - Service Néphrologie, transplantation, dialyse et aphérèse
Bordeaux, France, 33000
Réunion
Hopital Felix Guyon - Service d'Explorations Fonctionnelles Rénales
Saint-Denis, Réunion, 97400
Sponsors and Collaborators
University Hospital, Bordeaux
Institut National de la Santé Et de la Recherche Médicale, France
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03503461    
Other Study ID Numbers: CHUBX 2018/08
First Posted: April 19, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
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 University Hospital, Bordeaux:
Calcineurin inhibitors
hypertension
kidney transplant
acidosis
Gordon syndrome