Clinical trial NCT06903689: Pentoxifylline for Vascular Calcification in Kidney Disease
Official title: Exploring the Potential Effect of Pentoxifylline in Mitigating Vascular Calcification in Chronic Kidney Disease Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Chronic Kidney Disease
Vascular Calcification
Kidney Failure, Chronic
Keywords: Kidney Failure, Chronic
Vascular Calcification
Pentoxifylline
CKD
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2025-04-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Agatston Coronary Artery Calcification Score from Baseline to 6 Months
timeFrame: 6 Months
Secondary outcomes:
measure: Change in Estimated Glomerular Filtration Rate (eGFR) from Baseline to 6 Months
timeFrame: 6 Months
Other outcomes:
Locations:
Study officials:
References:
citation: Leporini C, Pisano A, Russo E, D Arrigo G, de Sarro G, Coppolino G, Bolignano D. Effect of pentoxifylline on renal outcomes in chronic kidney disease patients: A systematic review and meta-analysis. Pharmacol Res. 2016 May;107:315-332. doi: 10.1016/j.phrs.2016.03.001. Epub 2016 Mar 17.
citation: de Morales AM, Goicoechea M, Verde E, Carbayo J, Barbieri D, Delgado A, Verdalles U, de Jose AP, Luno J. Pentoxifylline, progression of chronic kidney disease (CKD) and cardiovascular mortality: long-term follow-up of a randomized clinical trial. J Nephrol. 2019 Aug;32(4):581-587. doi: 10.1007/s40620-019-00607-0. Epub 2019 Apr 4.
citation: Chen J, Budoff MJ, Reilly MP, Yang W, Rosas SE, Rahman M, Zhang X, Roy JA, Lustigova E, Nessel L, Ford V, Raj D, Porter AC, Soliman EZ, Wright JT Jr, Wolf M, He J; CRIC Investigators. Coronary Artery Calcification and Risk of Cardiovascular Disease and Death Among Patients With Chronic Kidney Disease. JAMA Cardiol. 2017 Jun 1;2(6):635-643. doi: 10.1001/jamacardio.2017.0363.