Major Activation Of NCC in Graft Urinary Exosomes

Kidney Transplantation Clinical Trial

— MANGUE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03503461
• Other study ID #: CHUBX 2018/08
• Status: Completed
• Start date: June 21, 2018
• Est. completion date: August 31, 2018

Study information

• Verified date: November 2018
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

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

Locations

Country	Name	City	State
France	Hopital Pellegrin - Service Néphrologie, transplantation, dialyse et aphérèse	Bordeaux
Réunion	Hopital Felix Guyon - Service d'Explorations Fonctionnelles Rénales	Saint-Denis

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Institut National de la Santé Et de la Recherche Médicale, France

Countries where clinical trial is conducted

France,  Réunion, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NCC cotransporter expression	Dosage of NCC cotransporter expression in urinary exosomes samples in both groups.	Inclusion day
Secondary	Phosphorylated NCC cotransporter expression	Dosage of phosphorylated NCC cotransporter expression in urinary exosomes samples in both groups.	Inclusion day
Secondary	pendrine expression in kidney transplant group	Dosage of pendrine expression in urinary exosomes samples in kidney transplant group.	Inclusion day