Pyrophosphate and Arterial Calcification in Chronic Kidney Disease

Chronic Kidney Diseases Clinical Trial

— Predical  

Official title:

Pyrophosphate: a New Biomarker to Predict Arterial Calcification in Chronic Kidney Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04950439
• Other study ID #: 19-API-02
• Status: Recruiting
• Phase: N/A
• Start date: March 14, 2022
• Est. completion date: March 14, 2028

Study information

• Verified date: September 2023
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Favre Guillaume, PhD
• Phone: 0492038428
• Email: favre.g[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 242
• Est. completion date: March 14, 2028
• Est. primary completion date: March 14, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	CHU de Nice	Nice	Alpes Maritimes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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