NCT03462238

Brief Summary

Arterial calcifications (AC) are constant lesions in patients with Chronic Kidney Diseases (CKD). Renal transplantation would reduce their progression compared to dialysis. AC pathophysiology is a complex and finely regulated process that involves many local and systemic factors, both pro- and anti-calcification. The progression of the CKD is accompanied by an increase in phosphate levels as the renal excretion capacity of inorganic phosphates (Pi) decreases while their digestive absorption remains unchanged. Hyperphosphatremia is a well-identified calcifying factor contributing to ACs in the CKD. On the other hand, pyrophosphate (PPi) is an anti-calcifying factor from the hydrolysis of extracellular ATP by ectonucleotidases. While there are many factors that may contribute to a protective effect against AC progression of renal transplantation, no study has been yet analysed the role of PPi. Plasma concentration of PPi is decreased in dialysis patients compared to non-kidney failure patients. The main objective of this monocentric, prospective and interventional pilot study will be to compare the progression of CA and \[PPi\]pl between a group of renal transplant patients over the past 24 months and a group of dialysis patients over the same period of time. The secondary objectives will be to compare the progression of ACs and the ratio\[PPi\]pl/\[Pi\]pl between transplanted and dialysis patients. Transplanted patients will be included within 24 (±3) months of transplant. Dialysis patients will be included at 24 (±3) months of the CT scan performed during the pre-transplant check-up. At inclusion, all patients will benefit from a CT scan without injection and a plasma dose of PPi, Pi and other factors involved in controlling calcification.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

January 12, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 12, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

September 10, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2020

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

1.1 years

First QC Date

January 12, 2018

Last Update Submit

May 5, 2023

Conditions

Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (2)

  • Concentration of plasma PPi

    at patient inclusion

  • Calcification score

    The calcification score is based on a computed tomography (CT) scan.

    at patient inclusion

Study Arms (2)

Kidney transplant patients

OTHER

Group of renal transplant patients for 24 months

Procedure: Blood collection for Ppi assayRadiation: CT Scan

Dialysis patients

OTHER

Group of dialysis patients for 24 months

Procedure: Blood collection for Ppi assayRadiation: CT Scan

Interventions

Blood collection for Ppi assayPROCEDURE

A 4.5 ml blood sample will be taken with a citrate vacuum tube.

Dialysis patientsKidney transplant patients
CT ScanRADIATION

A scanner will be performed

Dialysis patientsKidney transplant patients

Eligibility Criteria

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

You may qualify if:

  • Kidney transplant patients for 24 (±3) months or dialysis patients who have performed pre-transplant CT for 24 (±3) months
  • Major Patients
  • Informed patients who have signed informed consent
  • Patients of both sexes
  • Patients affiliated to the social security system

You may not qualify if:

  • Pregnancy in progress (checked by a previous ßHCG pregnancy test)
  • Patients not affiliated with social security
  • Patients not consenting or unable to understand the protocol and its development
  • Progressive cancer pathology
  • Patients under guardianship, under curatorship, protected by law

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Pasteur - Unité d'Exploration Fonctionelle Vasculaire

Nice, 06001, France

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Georges LEFTHERIOTIS, PU-PH

    Centre Hospitalier Universitaire de Nice

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2018

First Posted

March 12, 2018

Study Start

September 10, 2018

Primary Completion

October 28, 2019

Study Completion

October 28, 2020

Last Updated

May 6, 2023

Record last verified: 2023-05

Locations

FR(1)