- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04950439
Pyrophosphate and Arterial Calcification in Chronic Kidney Disease (Predical)
September 5, 2023 updated by: Centre Hospitalier Universitaire de Nice
Pyrophosphate: a New Biomarker to Predict Arterial Calcification in Chronic Kidney Disease
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
242
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Favre Guillaume, PhD
- Phone Number: 0492038428
- Email: favre.g@chu-nice.fr
Study Locations
-
-
Alpes Maritimes
-
Nice, Alpes Maritimes, France, 06001
- Recruiting
- CHU de Nice
-
Contact:
- Favre Guillaume, PhD
- Phone Number: 0492038428
- Email: favre.g@chu-nice.fr
-
Principal Investigator:
- Favre Guillaume, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Myocardial CT
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma levels of PPI
Time Frame: 3 years
|
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
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Favre Guillaume, PhD, CHU de Nice, Service de Néphrologie
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 14, 2022
Primary Completion (Estimated)
March 14, 2025
Study Completion (Estimated)
March 14, 2028
Study Registration Dates
First Submitted
June 29, 2021
First Submitted That Met QC Criteria
June 29, 2021
First Posted (Actual)
July 6, 2021
Study Record Updates
Last Update Posted (Estimated)
September 6, 2023
Last Update Submitted That Met QC Criteria
September 5, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-API-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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.
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