Chronic Kidney DiseasesPhase 3NCT05284656
Effect of Folic Acid and/or Pentoxifylline on Patients With Chronic Kidney Disease
A Phase 3 study testing combination of Pentoxifylline 400 MG and Folic Acid, folic acid and Pentoxifylline 400 MG in people with Chronic Kidney Diseases, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the effect of administration of folic acid and /or pentoxifylline on patients with chronic kidney disease (CKD). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- combination of Pentoxifylline 400 MG and Folic Acid, folic acid and Pentoxifylline 400 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Jan 2022to 19 Dec 2026
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients who have chronic kidney disease(CKD) stages 3-5
- Aged between18 - 60 years old.
- Both sexes.
- Stable clinical condition defined as no hospitalizations or cardiovascular events within the 3 months before screening
- Stable renal function (baseline serum creatinine had to have not increased by 50% in the 3 months before screening)
- No changes in concomitant medication during the study.
- Patients who accept to participate in the study.
Who cannot join
- Pregnant women
- Current use of PTF
- Contraindication to use of PTF drug: history of PTF or theophylline allergy, history of severe retinal hemorrhage or recent cerebral hemorrhage
- Those with active infections or inflammatory diseases or HIV infection
- Those with chronic liver disease .
- Patients who had received immunosuppressive therapy
- Non-compliant patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Potential Nephro-protective Effect of Folic Acid and/or Pentoxifylline on Patients With Chronic Kidney Disease
The aim of this study is to evaluate the effect of administration of folic acid and /or pentoxifylline on patients with chronic kidney disease (CKD).
Read the detailed description
Chronic kidney disease (CKD) is a worldwide public health problem, with adverse outcomes of kidney failure, cardiovascular disease (CVD), and premature death. Chronic kidney disease (CKD) affects between 8% and 16% of the population worldwide.Defined by a glomerular filtration rate (GFR) of less than 60 mL/min/1.73 m2, albuminuria of at least 30 mg per 24 hours, or markers of kidney damage (eg, hematuria or structural abnormalities such as polycystic or dysplastic kidneys) persisting for more than 3 months.That nutrient loss because of diet restriction and chronic inflammation contributed by CKD itself may stimulate progression in advanced chronic kidney disease. Folic acid was then selected as a nutrient intervention. In the mean time, pentoxifylline was well studied in this field for its anti-inflammatory effects.Pentoxifylline (PTF) appears to improve circulation through its ability to alter erythrocyte deformability and enhances capillary microcirculation. This hemorheological property and the potential capacity in decreasing intraglomerular pressure has led to recent interest in PTF as a therapeutic agent in patients with kidney disease. In addition to these properties, PTF has an effect on inflammation, oxidative stress and endothelial function.
- Conditions
- Chronic Kidney Diseases
- Being tested
- combination of Pentoxifylline 400 MG and Folic Acid, folic acid, Pentoxifylline 400 MG
- 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.
combination of Pentoxifylline 400 MG and Folic AcidDrug
Also called combination of Trental SR 400mg and Folic acid
drugs used to delay progression of chronic kidney disease
folic acidDrug
drugs used to delay progression of chronic kidney disease
Pentoxifylline 400 MGDrug
Also called Trental SR 400mg
drugs used to delay progression of chronic kidney disease
| Study group | Role | What they receive |
|---|---|---|
| folic acid Group | Experimental | 20 patients will receive folic acid 500 µg per day with their standard therapy for 6 months. Receives: Drug: folic acid |
| Pentoxifylline Group | Experimental | 20 patients will receive Pentoxifylline ( TRENTAL® Tablets, 400 mg) twice daily with their standard therapy for 6 months. Receives: Drug: Pentoxifylline 400 MG |
| folic acid and pentoxifylline Group | Experimental | 20 patients will receive combination therapy of folic acid5 mg per day and pentoxifylline ( TRENTAL® Tablets, 400 mg) twice daily with their standard therapy for 6 months Receives: Drug: combination of Pentoxifylline 400 MG and Folic Acid |
| control group | No intervention | 20 patients will receive their standard therapy only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Creatinine Level
Change was calculated as the value at 6 months minus the value at baseline.
Measured: Baseline, 6 months
Secondary outcomes (1)
Serum Ferritin in ng/ml
increase in serum ferritin from baseline
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start8 Jan 2022
- Primary completion12 Jun 2026 (estimated)
- Study completion19 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Reda Muhammad Galal, Al-Azhar University
- Investigators
- Zeinab AlKasaby, Principal investigator, Professor and Head of Clinical Pharmacy Department, Faculty of Pharmacy (Girls), Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05284656
- Sponsor's protocol ID
- Interventional
- Status last verified
- Jun 2025
- First submitted
- 16 Feb 2022
- Last updated
- 11 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Galal ARM, Teama NM, Abu-Elfotuha K, Alatawi AD, Alshareef H, Hamdan AME, Aljabri A, Alshibani M, Zalat ZAM. The potential adding therapeutic effect of pentoxifylline and/or folic acid for chronic kidney disease patients: randomized controlled trial. BMC Nephrol. 2025 Aug 18;26(1):468. doi: 10.1186/s12882-025-04399-3.
PubMed 40826392
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential Nephro-protective Effect of Folic Acid and/or Pentoxifylline on Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT05284656
- Acronym / sponsor ID
- Interventional
- Conditions
- Chronic Kidney Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 8 Jan 2022 (actual)
- Primary completion
- 12 Jun 2026 (estimated)
- Study completion
- 19 Dec 2026 (estimated)
- First posted
- 17 Mar 2022 (actual)
- Results
- Posted 11 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the effect of administration of folic acid and /or pentoxifylline on patients with chronic kidney disease (CKD).
Detailed description
Chronic kidney disease (CKD) is a worldwide public health problem, with adverse outcomes of kidney failure, cardiovascular disease (CVD), and premature death. Chronic kidney disease (CKD) affects between 8% and 16% of the population worldwide.Defined by a glomerular filtration rate (GFR) of less than 60 mL/min/1.73 m2, albuminuria of at least 30 mg per 24 hours, or markers of kidney damage (eg, hematuria or structural abnormalities such as polycystic or dysplastic kidneys) persisting for more than 3 months.That nutrient loss because of diet restriction and chronic inflammation contributed by CKD itself may stimulate progression in advanced chronic kidney disease. Folic acid was then selected as a nutrient intervention. In the mean time, pentoxifylline was well studied in this field for its anti-inflammatory effects.Pentoxifylline (PTF) appears to improve circulation through its ability to alter erythrocyte deformability and enhances capillary microcirculation. This hemorheological property and the potential capacity in decreasing intraglomerular pressure has led to recent interest in PTF as a therapeutic agent in patients with kidney disease. In addition to these properties, PTF has an effect on inflammation, oxidative stress and endothelial function.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| folic acid Group | Experimental | Drug: folic acid20 patients will receive folic acid 500 µg per day with their standard therapy for 6 months. |
| Pentoxifylline Group | Experimental | Drug: Pentoxifylline 400 MG20 patients will receive Pentoxifylline ( TRENTAL® Tablets, 400 mg) twice daily with their standard therapy for 6 months. |
| folic acid and pentoxifylline Group | Experimental | Drug: combination of Pentoxifylline 400 MG and Folic Acid20 patients will receive combination therapy of folic acid5 mg per day and pentoxifylline ( TRENTAL® Tablets, 400 mg) twice daily with their standard therapy for 6 months |
| control group | No intervention | –20 patients will receive their standard therapy only. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients who have chronic kidney disease(CKD) stages 3-5
- Aged between18 - 60 years old.
- Both sexes.
- Stable clinical condition defined as no hospitalizations or cardiovascular events within the 3 months before screening
- Stable renal function (baseline serum creatinine had to have not increased by 50% in the 3 months before screening)
Key exclusion criteria (7 listed)
- Pregnant women
- Current use of PTF
- Contraindication to use of PTF drug: history of PTF or theophylline allergy, history of severe retinal hemorrhage or recent cerebral hemorrhage
- Those with active infections or inflammatory diseases or HIV infection
- Those with chronic liver disease .
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 |
|---|---|---|
| combination of Pentoxifylline 400 MG and Folic AcidAlso: combination of Trental SR 400mg and Folic aciddrugs used to delay progression of chronic kidney disease | Drug | folic acid and pentoxifylline Group |
| folic aciddrugs used to delay progression of chronic kidney disease | Drug | folic acid Group |
| Pentoxifylline 400 MGAlso: Trental SR 400mgdrugs used to delay progression of chronic kidney disease | Drug | Pentoxifylline Group |
Primary outcome
Change in Serum Creatinine Level
Time frame: Baseline, 6 months
Change was calculated as the value at 6 months minus the value at baseline.
1 secondary outcome
Serum Ferritin in ng/ml
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40826392Galal ARM, Teama NM, Abu-Elfotuha K, Alatawi AD, Alshareef H, Hamdan AME, Aljabri A, Alshibani M, Zalat ZAM. The potential adding therapeutic effect of pentoxifylline and/or folic acid for chronic kidney disease patients: randomized controlled trial. BMC Nephrol. 2025 Aug 18;26(1):468. doi: 10.1186/s12882-025-04399-3.
- Individual participant dataSharing planned: No
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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.
Zeinab AlKasaby principal investigator
Professor and Head of Clinical Pharmacy Department, Faculty of Pharmacy (Girls), Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing combination of Pentoxifylline 400 MG and Folic Acid, folic acid and Pentoxifylline 400 MG in people with Chronic Kidney Diseases, run by Al-Azhar 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 7 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 11 Jun 2025. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Serum Creatinine Level (time frame: Baseline, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05284656, which also lists 1 linked publication.
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 11 Jun 2025; AzTrials last refreshed its copy on 8 Nov 2026.