PentoxifyllineNCT07315139
Pentoxifylline on Inflammatory Markers in Non-Diabetic Chronic Kidney Disease Patients
A study testing Angiotensin-converting enzyme inhibitors (Ramipril) and Pentoxifylline in people with Pentoxifylline and Inflammatory Markers, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aimed to determine the impact of Pentoxifylline on inflammatory biomarkers and the progression of chronic kidney disease in non-diabetic patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pentoxifylline, Inflammatory Markers, Non-Diabetic
- What is being tested?
- Angiotensin-converting enzyme inhibitors (Ramipril) and Pentoxifylline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ˃ 18 years old.
- Both sexes.
- Patients with chronic kidney disease (CKD) stages G3, G4.
- Patients with proteinuria < 1 g.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Angiotensin-converting enzyme inhibitors (Ramipril), Pentoxifylline
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angiotensin-converting enzyme inhibitors (Ramipril)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.
PentoxifyllineDrug
Patients received one capsule of Pentoxifylline 400 mg twice daily for 6 months, in addition to their standard therapy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Pentoxifylline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of inflammatory marker
Levels of inflammatory marker was recorded.
Measured: 3 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start1 Feb 2023
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PentoxifyllineStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashraf Hassan, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07315139
- Sponsor's protocol ID
- FMASU MS 53/2023
- Status last verified
- Dec 2025
- First submitted
- 18 Dec 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pentoxifylline on Inflammatory Markers in Non-Diabetic Chronic Kidney Disease Patients
- ClinicalTrials.gov ID
- NCT07315139
- Acronym / sponsor ID
- FMASU MS 53/2023
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | 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. |
| Group 2 | Experimental | Drug: PentoxifyllinePatients received one capsule of Pentoxifylline 400 mg twice daily for 6 months, in addition to their standard therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ˃ 18 years old.
- Both sexes.
- Patients with chronic kidney disease (CKD) stages G3, G4.
- Patients with proteinuria < 1 g.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Group 1 |
| PentoxifyllinePatients received one capsule of Pentoxifylline 400 mg twice daily for 6 months, in addition to their standard therapy. | Drug | Group 2 |
Primary outcome
Levels of inflammatory marker
Time frame: 3 months post-procedure
Levels of inflammatory marker was recorded.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Related trials for Pentoxifylline
Active, not recruitingPhase 4
Pentoxifylline in Diabetic Kidney Disease
Diabetic Kidney Disease
Not yet recruiting
Pentoxifylline Add-On Therapy for Mild-to-Moderate Plaque Psoriasis
Psoriasis
RecruitingPhase 2
Pentoxifylline as Anti-Inflammatory in Patients With Rheumatoid Arthritis
Rheumatoid Arthritis
RecruitingPhase 2
Systemic Therapy of Open-label Prophylactic Pravastatin or Pentoxifylline/Tocopherol Prevention of Lymphedema Advancing to Eventual Fibrosis: an Interventional Registry-embedded Bayesian Randomized Trial for Radiation Sequelae (STOP4-LATE-FIBROSE)
Lymphedema, Fibrosis
RecruitingPhase 2
Pneumonitis Prevention Protocol Using Pentoxifylline and α-tocopherol In Stage III Non-Small Cell Lung Cancer Patients Undergoing Chemoradiation
Non-Small Cell Lung Cancer, Radiation Induced Lung Injury (RILI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Angiotensin-converting enzyme inhibitors (Ramipril) and Pentoxifylline in people with Pentoxifylline and Inflammatory Markers, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of inflammatory marker (time frame: 3 months post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.