Pentoxifylline for Vascular Calcification in Kidney Disease

NCT ID: NCT06903689

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-15
• Study Completion Date: 2025-10-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pentoxifylline Arm

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.

Group Type: EXPERIMENTAL

Pentoxifylline 400 MG Oral Tablet

Intervention Type: 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 Medication Group

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.

Group Type: ACTIVE_COMPARATOR

Conventional Medications for Chronic Kidney Disease

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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 treatments are individualized and not dictated by the study protocol, but follow standard clinical practice for CKD.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Dina Massoud Gaber

Resident in Nephrology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Dina M Gaber, M.B.B. Ch

Role: CONTACT

dinamasud11@gmail.com

+201010402101 ext. +201062376458

References

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.

Reference Type: BACKGROUND

PMID: 26995301 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30949987 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28329057 (View on PubMed)

Other Identifiers

MS.24.09.2905

Identifier Type: -

Identifier Source: org_study_id