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

February 20, 2018 updated by: Hopital Foch
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

117

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • AH-HP Hôpital Necker enfants malades
      • Suresnes, France, 92150
        • Hopital Foch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Renal Transplant
Biological: Biological sample
Procedure: Non invasive Arterial investigations
Procedure: Abdominal tomodensitometry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Carotid-femoral pulse wave velocity
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Sectional carotid stiffness
Time Frame: 12 months
12 months
Carotid intima-media thickness
Time Frame: 12 months
12 months
Endothelial function
Time Frame: 12 months
12 months
Arterial calcification
Time Frame: 12 months
12 months
Pulsed central veinous pressure
Time Frame: 12 months
12 months
Klotho concentration
Time Frame: 1 day
1 day
FGF23 concentration
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Foch

Investigators

  • Principal Investigator: Michel Delahousse, MD, Hopital Foch

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

January 28, 2014

Study Completion (Actual)

January 28, 2014

Study Registration Dates

First Submitted

October 28, 2016

First Submitted That Met QC Criteria

October 28, 2016

First Posted (Estimate)

November 1, 2016

Study Record Updates

Last Update Posted (Actual)

February 22, 2018

Last Update Submitted That Met QC Criteria

February 20, 2018

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2010/26
  • 2010-A00413-36 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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