NCT07315139

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

December 18, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 2, 2026

Completed
Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

7 months

First QC Date

December 18, 2025

Last Update Submit

December 18, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Levels of inflammatory marker

    Levels of inflammatory marker was recorded.

    3 months post-procedure

Study Arms (2)

Group 1

ACTIVE COMPARATOR

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)

Group 2

EXPERIMENTAL

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

Drug: Pentoxifylline

Interventions

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 1

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

Group 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, 11591, Egypt

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Angiotensin-Converting Enzyme InhibitorsRamiprilPentoxifylline

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Protease InhibitorsEnzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsTheobromineXanthinesPurinonesPurines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Internal Medicine and Nephrology, Faculty of Medicine, Ain shams University, Cairo, Egypt.

Study Record Dates

First Submitted

December 18, 2025

First Posted

January 2, 2026

Study Start

February 1, 2023

Primary Completion

August 31, 2023

Study Completion

August 31, 2023

Last Updated

January 2, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations