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

Not Applicable

Completed

• Conditions: Renal Transplant
• Interventions: Biological: Biological sample; Procedure: Non invasive Arterial investigations; Procedure: Abdominal tomodensitometry

• Registration Number: NCT02951442
• Lead Sponsor: Hopital Foch

Brief Summary

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

Not available

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2014-01-28
• Study Completion: 2014-01-28
• Study First Submitted: 2016-10-28
• Study First Submitted QC: 2016-10-28
• Study First Posted: 2016-11-01
• Status Verified: 2017-01
• Last Update Submitted: 2018-02-20
• Last Update Posted: 2018-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Renal Transplant	Abdominal tomodensitometry	-
Renal Transplant	Biological sample	-
Renal Transplant	Non invasive Arterial investigations	-

Primary Outcome Measures

Name	Time	Method
Carotid-femoral pulse wave velocity	12 months

Secondary Outcome Measures

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

Trial Locations

Locations (2)

AH-HP Hôpital Necker enfants malades; 🇫🇷 Paris, France

Hôpital Foch; 🇫🇷 Suresnes, France