Clinical trial NCT03503461: Major Activation Of NCC in Graft Urinary Exosomes
Official title: Evaluation of the Prevalence of an Hyperactivation of NCC Cotransporter Three Months After Kidney Transplantation in Recipients Treated by Calcineurin Inhibitors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplantation
Keywords: Calcineurin inhibitors
hypertension
kidney transplant
acidosis
Gordon syndrome
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2018-04-19
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: NCC cotransporter expression
timeFrame: Inclusion day
Secondary outcomes:
measure: Phosphorylated NCC cotransporter expression
timeFrame: Inclusion day
measure: pendrine expression in kidney transplant group
timeFrame: Inclusion day
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Hopital Pellegrin - Service Néphrologie, transplantation, dialyse et aphérèse
city: Saint-Denis
country: Réunion
facility: Hopital Felix Guyon - Service d'Explorations Fonctionnelles Rénales
Study officials:
References: