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

Renal Transplant Clinical Trial

— KLOTHO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02951442
• Other study ID #: 2010/26
• Secondary ID: 2010-A00413-36
• Status: Completed
• Phase: N/A
• First received: October 28, 2016
• Last updated: February 20, 2018
• Start date: January 2011
• Est. completion date: January 28, 2014

Study information

• Verified date: January 2017
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: January 28, 2014
• Est. primary completion date: January 28, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Renal Transplant

Intervention

Biological:
• Biological sample

Procedure:
• Non invasive Arterial investigations

• Abdominal tomodensitometry

Locations

Country	Name	City	State
France	AH-HP Hôpital Necker enfants malades	Paris
France	Hôpital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Carotid-femoral pulse wave velocity		12 months
Secondary	Sectional carotid stiffness		12 months
Secondary	Carotid intima-media thickness		12 months
Secondary	Endothelial function		12 months
Secondary	Arterial calcification		12 months
Secondary	Pulsed central veinous pressure		12 months
Secondary	Klotho concentration		1 day
Secondary	FGF23 concentration		1 day