Pentoxifylline for Vascular Calcification in Kidney Disease

Phase 1

Not yet recruiting

• Conditions: Chronic Kidney Disease; Vascular Calcification; Kidney Failure, Chronic
• Interventions: Drug: Pentoxifylline 400 MG Oral Tablet; Other: Conventional Medications for Chronic Kidney Disease

• Registration Number: NCT06903689
• Lead Sponsor: Mansoura University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-25
• Study First Submitted QC: 2025-03-25
• Last Update Submitted: 2025-03-25
• Study First Posted: 2025-04-01
• Last Update Posted: 2025-04-01
• Study Start: 2025-04-15
• Primary Completion: 2025-10-15
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pentoxifylline Arm	Pentoxifylline 400 MG Oral Tablet	Participants in this arm will receive Pentoxifylline 400 mg twice daily orally with food, in addition to their conventional medications for chronic kidney disease (CKD). Pentoxifylline treatment will be administered for 6 months, concurrent with the study duration. Conventional medications will continue as prescribed by their treating physician and will be consistent with standard of care for CKD.
Conventional Medication Group	Conventional Medications for Chronic Kidney Disease	Participants in this arm will receive conventional medications for chronic kidney disease (CKD) only. They will not receive Pentoxifylline. Conventional medications will be administered as prescribed by their treating physician and will be consistent with standard of care for CKD. This arm serves as the control group to compare against the Pentoxifylline arm in evaluating the potential effect of Pentoxifylline on vascular calcification.

Primary Outcome Measures

Name	Time	Method
Change in Agatston Coronary Artery Calcification Score from Baseline to 6 Months	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.

Secondary Outcome Measures

Name	Time	Method
Change in Estimated Glomerular Filtration Rate (eGFR) from Baseline to 6 Months	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.