Pentoxifylline for Vascular Calcification in Kidney Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pentoxifylline 400 MG Oral Tablet, Conventional Medications for Chronic Kidney Disease.
- Who it may be relevant to
- Registry conditions: Chronic Kidney Disease, Vascular Calcification, Kidney Failure, Chronic. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Exploring the Potential Effect of Pentoxifylline in Mitigating Vascular Calcification in Chronic Kidney Disease Patients
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.
Interventions
- Drug Pentoxifylline 400 MG Oral Tablet
Oral tablet, 400 mg, administered twice daily with food for 6 months. To be taken in addition to conventional medications for chronic kidney disease. - Other Conventional Medications for Chronic Kidney Disease
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 treatm
Primary outcome measures
- Change in Agatston Coronary Artery Calcification Score from Baseline to 6 Months [Time frame: 6 Months]
Secondary outcome measures (1)
- Change in Estimated Glomerular Filtration Rate (eGFR) from Baseline to 6 Months [Time frame: 6 Months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- 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. PMID 26995301
- 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. PMID 30949987
- 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. PMID 28329057
Identifiers
NCT: NCT06903689 · MS.24.09.2905