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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03462238
Acronym
PyroCal-greffe
Enrollment
19
Registered
2018-03-12
Start date
2018-09-10
Completion date
2020-10-28
Last updated
2023-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Diseases

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.

Interventions

PROCEDUREBlood collection for Ppi assay

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

RADIATIONCT Scan

A scanner will be performed

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Concentration of plasma PPiat patient inclusion
Calcification scoreat patient inclusionThe calcification score is based on a computed tomography (CT) scan.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026