Pentoxifylline for Vascular Calcification in Kidney Disease

NCT06903689 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: MS.24.09.2905
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Kidney Disease; Vascular Calcification; Kidney Failure, Chronic

Keywords

Kidney Failure, Chronic; Vascular Calcification; Pentoxifylline; CKD

Outcome Measures

Primary Outcomes (1)

• 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.

  6 Months

Secondary Outcomes (1)

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

  6 Months

Study Arms (2)

Pentoxifylline Arm

EXPERIMENTAL

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.

Drug: Pentoxifylline 400 MG Oral Tablet

Conventional Medication Group

ACTIVE COMPARATOR

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.

Other: Conventional Medications for Chronic Kidney Disease

Interventions

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.

Pentoxifylline Arm

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.

Conventional Medication Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Vascular Calcification; Kidney Failure, Chronic

Interventions

Pentoxifylline; Tablets

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

Dina M Gaber, M.B.B. Ch

CONTACT

+201010402101; dinamasud11@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident in Nephrology

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 1, 2025
• Study Start: April 15, 2025
• Primary Completion: October 15, 2025
• Study Completion: October 30, 2025
• Last Updated: April 1, 2025

Record last verified: 2025-03