Major Activation Of NCC in Graft Urinary Exosomes

Completed

• Conditions: Kidney Transplantation
• Interventions: Other: exosomes analysis

• Registration Number: NCT03503461
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2018-04-11
• Study First Submitted QC: 2018-04-18
• Study First Posted: 2018-04-19
• Study Start: 2018-06-21
• Primary Completion: 2018-08-31
• Study Completion: 2018-08-31
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-12
• Last Update Posted: 2018-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
NCC cotransporter expression	Inclusion day	Dosage of NCC cotransporter expression in urinary exosomes samples in both groups.

Secondary Outcome Measures

Name	Time	Method
Phosphorylated NCC cotransporter expression	Inclusion day	Dosage of phosphorylated NCC cotransporter expression in urinary exosomes samples in both groups.
pendrine expression in kidney transplant group	Inclusion day	Dosage of pendrine expression in urinary exosomes samples in kidney transplant group.

Trial Locations

Locations (2)

Hopital Felix Guyon - Service d'Explorations Fonctionnelles Rénales; 🇷🇪 Saint-Denis, Réunion

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