Pentoxifylline on Inflammatory Markers in Non-Diabetic Chronic Kidney Disease Patients

Ain Shams University

Status: Completed

Conditions: Chronic Kidney Disease; Non-Diabetic; Pentoxifylline; Inflammatory Markers

Treatments: Drug: Pentoxifylline; Drug: Angiotensin-converting enzyme inhibitors (Ramipril)

Study type: Interventional

Funder types: Other

Identifiers

NCT07315139

FMASU MS 53/2023

Details and patient eligibility

About

This study aimed to determine the impact of Pentoxifylline on inflammatory biomarkers and the progression of chronic kidney disease in non-diabetic patients.

Full description

Chronic kidney disease (CKD) is a progressive condition that affects >10% of the general population worldwide, amounting to >800 million individuals.

The diagnosis of CKD is established by laboratory testing, most often by estimating glomerular filtration rate (GFR) from a filtration marker, such as serum creatinine or cystatin C, using various formulas, or by testing urine for albumin or protein (or both).

Pentoxifylline (PTX), a synthetic dimethylxanthine derivative used initially to treat intermittent claudication in patients with peripheral arterial disease due to its hemorheological effects, has been shown to have potent antioxidant, anti-inflammatory, antidiabetic, anti-cellular-damage, and antifibrotic effects.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ˃ 18 years old.
• Both sexes.
• Patients with chronic kidney disease (CKD) stages G3, G4.
• Patients with proteinuria < 1 g.

Exclusion criteria

• Patients who are terminally ill.
• Patients with Diabetes mellitus.
• Patients with proteinuria > 1 g.
• Patients with a history of hemodialysis.
• Patients with active infection or hospitalized.
• Patients with recent cerebral and /or retinal Hemorrhage.
• Patients taking warfarin or theophylline-containing drugs.
• women who are taking oral contraceptives, pregnant, or lactating
• Patients with a history of adverse reactions to Pentoxifylline.
• Patients with polycystic kidney disease.
• Patients with obstructive uropathy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Group 1

Active Comparator group

Description:

Patients received the standard therapy. The routine standard consisted of angiotensin-converting enzyme inhibitors (ACEI) (Ramipril 1.25 mg), a calcium-based phosphate binder (calcium acetate 700 mg, containing 180 mg of calcium), alfacalcidol (0.25 µg), antihypertensive medications, and diuretics.

Treatment:

Drug: Angiotensin-converting enzyme inhibitors (Ramipril)

Group 2

Experimental group

Description:

Patients received one capsule of Pentoxifylline 400 mg twice daily for 6 months, in addition to their standard therapy.

Treatment:

Drug: Pentoxifylline