Determinants of Vascular Calcification in Chronic Renal Failure : Impact of Pyrophosphate Levels After Renal Transplantation

NCT ID: NCT03462238

Last Updated: 2023-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-10

Study Completion Date

2020-10-28

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Kidney Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Kidney transplant patients

Group of renal transplant patients for 24 months

Group Type OTHER

Blood collection for Ppi assay

Intervention Type PROCEDURE

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

CT Scan

Intervention Type RADIATION

A scanner will be performed

Dialysis patients

Group of dialysis patients for 24 months

Group Type OTHER

Blood collection for Ppi assay

Intervention Type PROCEDURE

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

CT Scan

Intervention Type RADIATION

A scanner will be performed

Interventions

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Blood collection for Ppi assay

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

Intervention Type PROCEDURE

CT Scan

A scanner will be performed

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Pregnancy in progress (checked by a previous ßHCG pregnancy test)
* Patients whose clinical condition would not allow inclusion in the study.
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Georges LEFTHERIOTIS, PU-PH

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nice

Locations

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Hôpital Pasteur - Unité d'Exploration Fonctionelle Vasculaire

Nice, , France

Site Status

Countries

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France

Other Identifiers

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17-AOI-02

Identifier Type: -

Identifier Source: org_study_id

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