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

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease; Inflammatory Markers; Pentoxifylline; Non-Diabetic
• Intervention / Treatment: Drug: Angiotensin-converting enzyme inhibitors (Ramipril); Drug: Pentoxifylline

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11591
    • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; 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.	Drug: Angiotensin-converting enzyme inhibitors (Ramipril); 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.
Experimental: Group 2; Patients received one capsule of Pentoxifylline 400 mg twice daily for 6 months, in addition to their standard therapy.	Drug: Pentoxifylline; Patients received one capsule of Pentoxifylline 400 mg twice daily for 6 months, in addition to their standard therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Levels of inflammatory marker	Levels of inflammatory marker was recorded.	3 months post-procedure

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: December 18, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Estimated): January 2, 2026

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Molecular Mechanisms of Pharmacological Action; Protease Inhibitors; Enzyme Inhibitors; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pharmacologic Actions; Chemical Actions and Uses; Purinones; Purines; Xanthines; Theobromine; Ramipril; Angiotensin-Converting Enzyme Inhibitors; Pentoxifylline
• Other Study ID Numbers: FMASU MS 53/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No