Pentoxifylline for Vascular Calcification in Kidney Disease

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Chronic Kidney Disease Calcinosis Calcium Metabolism Disorders Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Calcification

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pentoxifylline 400 mg Oral Tablet

Drug

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 Disease

Other

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.

Primary outcomes

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

Time frame: 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 outcomes

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

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dina M Gaber, M.B.B. Ch

CONTACT

[email protected]

+201010402101 ext. +201062376458

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Exploring the Potential Effect of Pentoxifylline in Mitigating Vascular Calcification in Chronic Kidney Disease Patients

Acronym: PTX-CALC-CKD

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Apr 1, 2025
Registry last updated: Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed