Pyrophosphate and Arterial Calcification in Chronic Kidney Disease

NCT04950439 | Active Not Recruiting

• 1 other identifier: 19-API-02
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

• 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

  3 years

Study Arms (1)

Myocardial CT

OTHER

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.

Other: Collect blood sample

Interventions

Collect blood sample 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.

Myocardial CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• kidney transplantation
• acute inflammatory disease or active cancer

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, Alpes Maritimes, 06001, France

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Favre Guillaume, PhD

  CHU de Nice, Service de Néphrologie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: July 6, 2021
• Study Start: March 14, 2022
• Primary Completion (Estimated): March 14, 2028
• Study Completion (Estimated): March 14, 2029
• Last Updated: May 20, 2026

Record last verified: 2025-07

Locations

FR (1)