Major Activation Of NCC in Graft Urinary Exosomes

NCT03503461 | Completed

• 1 other identifier: CHUBX 2018/08
• Study Type: observational
• Target: 67
• Locations: 2 countries
• Sites: 2

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.

Conditions

Kidney Transplantation

Keywords

Calcineurin inhibitors; hypertension; kidney transplant; acidosis; Gordon syndrome

Outcome Measures

Primary Outcomes (1)

• NCC cotransporter expression

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

  Inclusion day

Secondary Outcomes (2)

• Phosphorylated NCC cotransporter expression

  Inclusion day

• pendrine expression in kidney transplant group

  Inclusion day

Study Arms (2)

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

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

Interventions

exosomes analysis OTHER

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

Control group; Kidney transplants group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age≥18years
• Recipients three months after kidney transplantation using calcineurin inhibitors
• Glomerular Filtration Rate\>15ml.mn.m2 CKD-EPI
• No opposition at participating at the research

You may not qualify if:

• Graft artery stenosis with indication of interventional radiology or surgery
• For control group :
• No previous transplantation
• Age≥18years
• No hypertension
• No metabolic disorders (dysnatremia, dyskaliemia, acidosis or alkalosis)
• No opposition at participating at the research

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (2)

Hopital Pellegrin - Service Néphrologie, transplantation, dialyse et aphérèse

Bordeaux, 33000, France

Location

Hopital Felix Guyon - Service d'Explorations Fonctionnelles Rénales

Saint-Denis, 97400, Reunion

Location

MeSH Terms

Conditions

Hypertension; Acidosis; Gordon syndrome

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: April 19, 2018
• Study Start: June 21, 2018
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: November 14, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

RE (1); FR (1)