Pyrophosphate and Arterial Calcification in Chronic Kidney Disease (Predical)
Primary Purpose
Chronic Kidney Diseases
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Collect blood sample
Sponsored by
About this trial
This is an interventional other trial for Chronic Kidney Diseases
Eligibility Criteria
Inclusion Criteria:
- eGFR between 59 et 20 ml/min/1,73 m2 twice at three month interval
Exclusion Criteria:
- kidney transplantation
- acute inflammatory disease or active cancer
Sites / Locations
- CHU de NiceRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Myocardial CT
Arm Description
The investigator will collect the usual clinical history and data. Risk factors and cardiovascular events are identified. A blood sample dedicated to the study and necessary for routine care is taken. The pulse wave velocity and systolic pressure index are measured. A myocardial CT scan coupled with a computed tomography is performed. The patient collects stools at his home, simply conditions them and sends them by mail to the centre, which stores them.
Outcomes
Primary Outcome Measures
Plasma levels of PPI
To show that low plasma levels of PPi at baseline is associated with a high progression of arterial calcification at three years after adjustment for confounding variables
Secondary Outcome Measures
Full Information
NCT ID
NCT04950439
First Posted
June 29, 2021
Last Updated
September 5, 2023
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT04950439
Brief Title
Pyrophosphate and Arterial Calcification in Chronic Kidney Disease
Acronym
Predical
Official Title
Pyrophosphate: a New Biomarker to Predict Arterial Calcification in Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 14, 2022 (Actual)
Primary Completion Date
March 14, 2025 (Anticipated)
Study Completion Date
March 14, 2028 (Anticipated)
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 start at early stages of chronic kidney disease (CKD) and are associated to cardiovascular mortality. Pyrophosphate (PPi) is an endogenous compound, which stops the mineralization process in bones and is expected to act at ectopic sites. In uremic rats, low PPi plasma levels are associated with high calcium content in the aorta and peritoneal administration of PPi blocks this process. People on maintenance dialysis or kidney transplant recipients have low plasma levels of PPi and show high scores of arterial calcification. The purpose is to determine the role of low PPi in the development of arterial calcifications in patients with CKD stage 3 or 4. To that aim, 252 patients with eGFR between 59 et 20 ml/min/1,73 m2 will be recruited and will be examined at baseline and three years later.
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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
242 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Myocardial CT
Arm Type
Other
Arm Description
The investigator will collect the usual clinical history and data. Risk factors and cardiovascular events are identified. A blood sample dedicated to the study and necessary for routine care is taken. The pulse wave velocity and systolic pressure index are measured. A myocardial CT scan coupled with a computed tomography is performed. The patient collects stools at his home, simply conditions them and sends them by mail to the centre, which stores them.
Intervention Type
Other
Intervention Name(s)
Collect blood sample
Intervention Description
A blood sample dedicated to the study and necessary for routine care is taken. The pulse wave velocity and systolic pressure index are measured. A myocardial CT scan coupled with a computed tomography is performed. The patient collects stools at his home, simply conditions them and sends them by mail to the centre, which stores them.
Primary Outcome Measure Information:
Title
Plasma levels of PPI
Description
To show that low plasma levels of PPi at baseline is associated with a high progression of arterial calcification at three years after adjustment for confounding variables
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
eGFR between 59 et 20 ml/min/1,73 m2 twice at three month interval
Exclusion Criteria:
kidney transplantation
acute inflammatory disease or active cancer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Favre Guillaume, PhD
Phone
0492038428
Email
favre.g@chu-nice.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Favre Guillaume, PhD
Organizational Affiliation
CHU de Nice, Service de Néphrologie
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nice
City
Nice
State/Province
Alpes Maritimes
ZIP/Postal Code
06001
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Favre Guillaume, PhD
Phone
0492038428
Email
favre.g@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Favre Guillaume, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Pyrophosphate and Arterial Calcification in Chronic Kidney Disease
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