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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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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