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

NCT ID: NCT07315139

Last Updated: 2026-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2023-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Pentoxifylline Inflammatory Markers Non-Diabetic Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Angiotensin-converting enzyme inhibitors (Ramipril)

Intervention Type DRUG

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.

Group 2

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

Group Type EXPERIMENTAL

Pentoxifylline

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Pentoxifylline

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Ashraf Hassan

Assistant Professor of Internal Medicine and Nephrology, Faculty of Medicine, Ain shams University, Cairo, Egypt.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain Shams University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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FMASU MS 53/2023

Identifier Type: -

Identifier Source: org_study_id

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