Pentoxifylline for Vascular Calcification in Kidney Disease (PTX-CALC-CKD)

Mansoura University

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Chronic Kidney Disease; Vascular Calcification; Kidney Failure, Chronic

Treatments: Other: Conventional Medications for Chronic Kidney Disease; Drug: Pentoxifylline 400 MG Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT06903689

MS.24.09.2905

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

80 participants in 2 patient groups

Pentoxifylline Arm

Experimental group

Description:

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.

Treatment:

Drug: Pentoxifylline 400 MG Oral Tablet

Conventional Medication Group

Active Comparator group

Description:

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.

Treatment:

Other: Conventional Medications for Chronic Kidney Disease