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

Chronic Kidney Diseases Clinical Trial

— PyroCal-greffe  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03462238
• Other study ID #: 17-AOI-02
• Status: Completed
• Phase: N/A
• Start date: September 10, 2018
• Est. completion date: October 28, 2020

Study information

• Verified date: May 2023
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: October 28, 2020
• Est. primary completion date: October 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency
• Renal Insufficiency, Chronic
• Vascular Calcification

Intervention

Procedure:
• Blood collection for Ppi assay
A 4.5 ml blood sample will be taken with a citrate vacuum tube.

Radiation:
• CT Scan
A scanner will be performed

Locations

Country	Name	City	State
France	Hôpital Pasteur - Unité d'Exploration Fonctionelle Vasculaire	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of plasma PPi		at patient inclusion
Primary	Calcification score	The calcification score is based on a computed tomography (CT) scan.	at patient inclusion