Pyrophosphate and Arterial Calcification in Chronic Kidney Disease

NCT ID: NCT04950439

Last Updated: 2024-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

242 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-14

Study Completion Date

2028-03-14

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Kidney Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Collect blood sample

Intervention Type OTHER

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.

Interventions

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Collect blood sample

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

Eligibility Criteria

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Inclusion Criteria

* eGFR between 59 et 20 ml/min/1,73 m2 twice at three month interval

Exclusion Criteria

1. kidney transplantation
2. acute inflammatory disease or active cancer
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Favre Guillaume, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de Nice, Service de Néphrologie

Locations

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CHU de Nice

Nice, Alpes Maritimes, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Favre Guillaume, PhD

Role: CONTACT

0492038428

Facility Contacts

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Favre Guillaume, PhD

Role: primary

0492038428

Other Identifiers

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19-API-02

Identifier Type: -

Identifier Source: org_study_id

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