Determinants of Vascular Calcification in Chronic Renal Failure : Impact of Pyrophosphate Levels After Renal Transplantation (PyroCal-greffe)
Primary Purpose
Chronic Kidney Diseases
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood collection for Ppi assay
CT Scan
Sponsored by
About this trial
This is an interventional other trial for Chronic Kidney Diseases
Eligibility Criteria
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
Sites / Locations
- Hôpital Pasteur - Unité d'Exploration Fonctionelle Vasculaire
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Kidney transplant patients
Dialysis patients
Arm Description
Group of renal transplant patients for 24 months
Group of dialysis patients for 24 months
Outcomes
Primary Outcome Measures
Concentration of plasma PPi
Calcification score
The calcification score is based on a computed tomography (CT) scan.
Secondary Outcome Measures
Full Information
NCT ID
NCT03462238
First Posted
January 12, 2018
Last Updated
May 5, 2023
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT03462238
Brief Title
Determinants of Vascular Calcification in Chronic Renal Failure : Impact of Pyrophosphate Levels After Renal Transplantation
Acronym
PyroCal-greffe
Official Title
Determinants of Vascular Calcification in Chronic Renal Failure : Impact of Pyrophosphate Levels After Renal Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 10, 2018 (Actual)
Primary Completion Date
October 28, 2019 (Actual)
Study Completion Date
October 28, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Kidney transplant patients
Arm Type
Other
Arm Description
Group of renal transplant patients for 24 months
Arm Title
Dialysis patients
Arm Type
Other
Arm Description
Group of dialysis patients for 24 months
Intervention Type
Procedure
Intervention Name(s)
Blood collection for Ppi assay
Intervention Description
A 4.5 ml blood sample will be taken with a citrate vacuum tube.
Intervention Type
Radiation
Intervention Name(s)
CT Scan
Intervention Description
A scanner will be performed
Primary Outcome Measure Information:
Title
Concentration of plasma PPi
Time Frame
at patient inclusion
Title
Calcification score
Description
The calcification score is based on a computed tomography (CT) scan.
Time Frame
at patient inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georges LEFTHERIOTIS, PU-PH
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Pasteur - Unité d'Exploration Fonctionelle Vasculaire
City
Nice
ZIP/Postal Code
06001
Country
France
12. IPD Sharing Statement
Learn more about this trial
Determinants of Vascular Calcification in Chronic Renal Failure : Impact of Pyrophosphate Levels After Renal Transplantation
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