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OpenTrials
Completed

NCT Number: NCT03462238

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Pasteur - Unité d'Exploration Fonctionelle Vasculaire

Nice, 06001, France

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Blood collection for Ppi assay

Procedure

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

CT Scan

Radiation

A scanner will be performed

Primary outcomes

  1. Concentration of plasma PPi

    Time frame: at patient inclusion

  2. Calcification score

    Time frame: at patient inclusion

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Acronym: PyroCal-greffe

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Mar 12, 2018
Registry last updated
May 6, 2023

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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