Identification of Markers (Klotho-FGF23 Axis) as Determinant in the Evolution of Arterial Stiffness During the First Year of Renal Transplant

NCT ID: NCT02951442

Last Updated: 2018-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2014-01-28

Brief Summary

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The primary objective is to show that the contribution of Klotho by the renal graft is an independent determinant of the evolution of the recipient's central arterial stiffness during the first year of renal transplant. The contribution of Klotho by the graft will be estimated by: its circulating concentrations assay, its urinary excretion assay, and, indirectly, by the circulating concentrations of FGF23. The recipient's central arterial stiffness will be estimated by the measure of the carotid-femoral pulse wave velocity, noninvasive reference method for measuring aortic stiffness in human.

Detailed Description

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Conditions

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Renal Transplant

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Renal Transplant

Group Type EXPERIMENTAL

Biological sample

Intervention Type BIOLOGICAL

Non invasive Arterial investigations

Intervention Type PROCEDURE

Abdominal tomodensitometry

Intervention Type PROCEDURE

Interventions

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Biological sample

Intervention Type BIOLOGICAL

Non invasive Arterial investigations

Intervention Type PROCEDURE

Abdominal tomodensitometry

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Man or woman 18 to 70 years old
* Renal transplant
* Dead donor or alive donor
* Immunosuppression including a calcineurin inhibitor
* Written consent

Exclusion Criteria

* MultipleTransplant
* Morbid Obesity (Body Mass Index (BMI)\> 40 kg/m2 sc)
* Cardiac Arrhythmia
* Lower limbs occlusive arterial disease
* Impossibility to understand the information form
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hopital Foch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michel Delahousse, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Foch

Locations

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AH-HP Hôpital Necker enfants malades

Paris, , France

Site Status

Hôpital Foch

Suresnes, , France

Site Status

Countries

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France

Other Identifiers

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2010-A00413-36

Identifier Type: OTHER

Identifier Source: secondary_id

2010/26

Identifier Type: -

Identifier Source: org_study_id

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