Pentoxifylline for Vascular Calcification in Kidney Disease

Phase 2Not Yet RecruitingNCT06903689

Mansoura University80 enrolled

Overview

This study is research to find out if the drug pentoxifylline can help prevent or lessen the problem of blood vessel hardening (vascular calcification) in people with chronic kidney disease (CKD). People with CKD are at higher risk for heart problems and blood vessel hardening. Vascular calcification happens when calcium builds up in the blood vessels, making them stiff. Pentoxifylline is a drug that might have helpful effects that could reduce this hardening. In this study, some CKD patients will receive pentoxifylline in addition to their usual medications, while others will only receive their usual medications. The researchers will then compare the amount of vascular calcification in both groups over 6 months to see if pentoxifylline makes a difference. The goal is to learn if pentoxifylline could be a new way to protect the blood vessels of people with chronic kidney disease.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Kidney Disease Vascular Calcification Kidney Failure, Chronic

Interventions

Pentoxifylline 400 MG Oral TabletDRUG

Oral tablet, 400 mg, administered twice daily with food for 6 months. To be taken in addition to conventional medications for chronic kidney disease.

Conventional Medications for Chronic Kidney DiseaseOTHER

This arm receives conventional medical management for chronic kidney disease (CKD). This includes medications and treatments as deemed necessary and appropriate by the participant's treating physician, according to established clinical guidelines for CKD. These may include, but are not limited to, medications for blood pressure control, management of diabetes, anemia treatment, mineral and bone disorder management, and fluid and electrolyte balance management. The specific medications and treatments are individualized and not dictated by the study protocol, but follow standard clinical practice for CKD.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Estimated Glomerular Filtration Rate (eGFR) less than 60 ml/min/1.73 m² and greater than or equal to 15 ml/min/1.73 m². * Adult patients, age 18 years or older. * Diagnosis of Chronic Kidney Disease (CKD). * Willing and able to provide informed consent. Exclusion Criteria: * Patients currently undergoing regular hemodialysis. * History of kidney transplantation or are kidney transplant recipients. * Pregnant females. * Patients with a history of coronary artery bypass grafting (CABG). * Known allergy or contraindication to pentoxifylline. * Inability to comply with study procedures or attend follow-up visits.

Outcomes

Primary Outcomes

Change in Agatston Coronary Artery Calcification Score from Baseline to 6 Months

The primary outcome measure is the change in coronary artery calcification as assessed by the Agatston score, measured from baseline to 6 months after the start of the intervention. Coronary artery calcification will be quantified using computed tomography (CT) scans and analyzed using the Agatston method. A higher Agatston score indicates a greater degree of coronary artery calcification. The change will be calculated as the difference between the Agatston score at 6 months and the Agatston score at baseline.

Time frame: 6 Months

Secondary Outcomes

Change in Estimated Glomerular Filtration Rate (eGFR) from Baseline to 6 Months

Change in estimated glomerular filtration rate (eGFR) will be assessed from baseline to 6 months. eGFR will be calculated using serum creatinine levels and a standard CKD-EPI equation. eGFR is a measure of kidney function, with lower values indicating poorer kidney function. The change will be calculated as the difference between the eGFR value at 6 months and the eGFR value at baseline.