MANGUE: Major Activation Of NCC in Graft Urinary Exosomes

• Sponsor: University Hospital, Bordeaux (Other)
• Overall Status: Completed
• CT.gov ID: NCT03503461
• Collaborator: Institut National de la Santé Et de la Recherche Médicale, France (Other)
• Enrollment: 67
• Locations: 2
• Actual Duration (Months): 2.3
• Patients Per Site: 33.5
• Patients Per Site Per Month: 14.4

Study Details

Study Description

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	Phase
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.

Study Design

• 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: Jun 21, 2018
• Actual Primary Completion Date: Aug 31, 2018
• Actual Study Completion Date: Aug 31, 2018

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. NCC cotransporter expression [Inclusion day]

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

Secondary Outcome Measures

1. Phosphorylated NCC cotransporter expression [Inclusion day]

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

2. pendrine expression in kidney transplant group [Inclusion day]

   Dosage of pendrine expression in urinary exosomes samples in kidney transplant group.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hopital Pellegrin - Service Néphrologie, transplantation, dialyse et aphérèse	Bordeaux		France	33000
2	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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Bordeaux
• ClinicalTrials.gov Identifier: NCT03503461
• Other Study ID Numbers: CHUBX 2018/08
• First Posted: Apr 19, 2018
• Last Update Posted: Nov 14, 2018
• Last Verified: Nov 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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

Study Results

No Results Posted as of Nov 14, 2018