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Completed

NCT Number: NCT03503461

Major Activation Of NCC in Graft Urinary Exosomes

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Pellegrin - Service Néphrologie, transplantation, dialyse et aphérèse, Bordeaux, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

exosomes analysis

Other

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

Primary outcomes

  1. NCC cotransporter expression

    Time frame: Inclusion day

    Dosage of NCC cotransporter expression in urinary exosomes samples in both groups.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Collaborators

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

Registry information

Official study title

Evaluation of the Prevalence of an Hyperactivation of NCC Cotransporter Three Months After Kidney Transplantation in Recipients Treated by Calcineurin Inhibitors

Acronym: MANGUE

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 19, 2018
Registry last updated
Nov 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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