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Completed

NCT Number: NCT02951442

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

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.

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Key information

Conditions

Renal Transplant

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AH-HP Hôpital Necker enfants malades, Paris, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

biological sample

Biological

Non invasive Arterial investigations

Procedure

Abdominal tomodensitometry

Procedure

Primary outcomes

  1. Carotid-femoral pulse wave velocity

    Time frame: 12 months

Secondary outcomes

  1. Sectional carotid stiffness

    Time frame: 12 months

  2. Carotid intima-media thickness

    Time frame: 12 months

  3. Endothelial function

    Time frame: 12 months

  4. Arterial calcification

    Time frame: 12 months

  5. Pulsed central veinous pressure

    Time frame: 12 months

  6. Klotho concentration

    Time frame: 1 day

  7. FGF23 concentration

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Acronym: KLOTHO

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Nov 1, 2016
Registry last updated
Feb 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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