Determinants of Vascular Calcification in Chronic Renal Failure : Impact of Pyrophosphate Levels After Renal Transplantation (PyroCal-greffe)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Nice, France, 06001
- Hôpital Pasteur - Unité d'Exploration Fonctionelle Vasculaire
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Kidney transplant patients
Group of renal transplant patients for 24 months
|
A 4.5 ml blood sample will be taken with a citrate vacuum tube.
A scanner will be performed
|
|
Other: Dialysis patients
Group of dialysis patients for 24 months
|
A 4.5 ml blood sample will be taken with a citrate vacuum tube.
A scanner will be performed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Concentration of plasma PPi
Time Frame: at patient inclusion
|
at patient inclusion
|
|
|
Calcification score
Time Frame: at patient inclusion
|
The calcification score is based on a computed tomography (CT) scan.
|
at patient inclusion
|
Collaborators and Investigators
Investigators
- Principal Investigator: Georges LEFTHERIOTIS, PU-PH, Centre Hospitalier Universitaire de Nice
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-AOI-02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.