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

Not Applicable

Completed

• Conditions: Chronic Kidney Diseases
• Interventions: Procedure: Blood collection for Ppi assay; Radiation: CT Scan

• Registration Number: NCT03462238
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-01-12
• Study First Submitted QC: 2018-03-09
• Study First Posted: 2018-03-12
• Study Start: 2018-09-10
• Primary Completion: 2019-10-28
• Study Completion: 2020-10-28
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-05
• Last Update Posted: 2023-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dialysis patients	CT Scan	Group of dialysis patients for 24 months
Dialysis patients	Blood collection for Ppi assay	Group of dialysis patients for 24 months
Kidney transplant patients	CT Scan	Group of renal transplant patients for 24 months
Kidney transplant patients	Blood collection for Ppi assay	Group of renal transplant patients for 24 months

Primary Outcome Measures

Name	Time	Method
Calcification score	at patient inclusion	The calcification score is based on a computed tomography (CT) scan.
Concentration of plasma PPi	at patient inclusion

Trial Locations

Locations (1)

Hôpital Pasteur - Unité d'Exploration Fonctionelle Vasculaire; 🇫🇷 Nice, France