NCT02951442

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2011

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2014

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

October 28, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 1, 2016

Completed
Last Updated

February 22, 2018

Status Verified

January 1, 2017

Enrollment Period

3.1 years

First QC Date

October 28, 2016

Last Update Submit

February 20, 2018

Conditions

Renal Transplant

Keywords

Arterial stiffnessKlotho-FGF23

Outcome Measures

Primary Outcomes (1)

  • Carotid-femoral pulse wave velocity

    12 months

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (1)

Renal Transplant

EXPERIMENTAL
Biological: Biological sampleProcedure: Non invasive Arterial investigationsProcedure: Abdominal tomodensitometry

Interventions

Biological sampleBIOLOGICAL
Renal Transplant
Non invasive Arterial investigationsPROCEDURE
Renal Transplant
Abdominal tomodensitometryPROCEDURE
Renal Transplant

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • MultipleTransplant
  • Morbid Obesity (Body Mass Index (BMI)\> 40 kg/m2 sc)
  • Cardiac Arrhythmia
  • Lower limbs occlusive arterial disease
  • Impossibility to understand the information form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

AH-HP Hôpital Necker enfants malades

Paris, 75015, France

Location

Hôpital Foch

Suresnes, 92150, France

Location

Study Officials

  • Michel Delahousse, MD

    Hopital Foch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2016

First Posted

November 1, 2016

Study Start

January 1, 2011

Primary Completion

January 28, 2014

Study Completion

January 28, 2014

Last Updated

February 22, 2018

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)