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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| folic acid Group | Experimental | 20 patients will receive folic acid 500 µg per day with their standard therapy for 6 months. |
|
| Pentoxifylline Group | Experimental | 20 patients will receive Pentoxifylline ( TRENTAL® Tablets, 400 mg) twice daily with their standard therapy for 6 months. |
|
| 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 |
|
| control group | No Intervention | 20 patients will receive their standard therapy only. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| combination of Pentoxifylline 400 MG and Folic Acid | Drug | drugs used to delay progression of chronic kidney disease |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Serum Creatinine Level | Change was calculated as the value at 6 months minus the value at baseline. | Baseline, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Ferritin in ng/ml | increase in serum ferritin from baseline | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Protein/ Creatinine Ratio(P/C) (mg Protein/mg Creatinine) | change in Protein/ creatinine ratio for determination of proteinuria | 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zeinab AlKasaby | Professor and Head of Clinical Pharmacy Department, Faculty of Pharmacy (Girls), Al-Azhar University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Al Azhar University | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40826392 | Derived | 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. |
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some patient are excluded from the study as they donnot meet the inclusion criteria
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| ID | Title | Description |
|---|---|---|
| FG000 | Folic Acid Group | 20 patients will receive folic acid 500 µg per day with their standard therapy for 6 months. folic acid: drugs used to delay progression of chronic kidney disease |
| FG001 | Pentoxifylline Group | 20 patients will receive Pentoxifylline ( TRENTAL® Tablets, 400 mg) twice daily with their standard therapy for 6 months. Pentoxifylline 400 MG: drugs used to delay progression of chronic kidney disease |
| FG002 | Folic Acid and Pentoxifylline Group | 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 combination of Pentoxifylline 400 MG and Folic Acid: drugs used to delay progression of chronic kidney disease |
| FG003 | Control Group | 20 patients will receive their standard therapy only. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Folic Acid Group | 20 patients will receive folic acid 500 µg per day with their standard therapy for 6 months. folic acid: drugs used to delay progression of chronic kidney disease |
| BG001 | Folic Acid and Pentoxifylline Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Serum Creatinine Level | Change was calculated as the value at 6 months minus the value at baseline. | Posted | Mean | Standard Deviation | mg/dl | Baseline, 6 months |
|
patient are followed up for 6 months for any adverse events
the drug is safe and approved by FDA and the assessment of adverse event was collected based on weekly questionnaire
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Folic Acid Group | 20 patients will receive folic acid 500 µg per day with their standard therapy for 6 months. folic acid: drugs used to delay progression of chronic kidney disease |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amira Reda Muhammad | Al-Azhar University | 0106 822 0389 | amira.reda89@hotmail.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 10, 2025 | Jun 10, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D005492 | Folic Acid |
| D010431 | Pentoxifylline |
| ID | Term |
|---|---|
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| folic acid | Drug | drugs used to delay progression of chronic kidney disease |
|
| Pentoxifylline 400 MG | Drug | drugs used to delay progression of chronic kidney disease |
|
|
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
combination of Pentoxifylline 400 MG and Folic Acid: drugs used to delay progression of chronic kidney disease
| BG002 | Pentoxifylline Group | 20 patients will receive Pentoxifylline ( TRENTAL® Tablets, 400 mg) twice daily with their standard therapy for 6 months. Pentoxifylline 400 MG: drugs used to delay progression of chronic kidney disease |
| BG003 | Control Group | 20 patients will receive their standard therapy only. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| glomular filtration rate | glomular filtration rate is measured from serum creatinine to measure kidney function | Mean | Standard Deviation | ml/min |
|
| OG002 |
| Folic Acid and Pentoxifylline Group |
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 combination of Pentoxifylline 400 MG and Folic Acid: drugs used to delay progression of chronic kidney disease |
| OG003 | Control Group | 20 patients will receive their standard therapy only. |
|
|
| Secondary | Serum Ferritin in ng/ml | increase in serum ferritin from baseline | Posted | Mean | Standard Deviation | ng/ml | 6 months |
|
|
|
| Other Pre-specified | Protein/ Creatinine Ratio(P/C) (mg Protein/mg Creatinine) | change in Protein/ creatinine ratio for determination of proteinuria | Not Posted | Dec 2025 | 6 months | Participants |
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Pentoxifylline Group | 20 patients will receive Pentoxifylline ( TRENTAL® Tablets, 400 mg) twice daily with their standard therapy for 6 months. Pentoxifylline 400 MG: drugs used to delay progression of chronic kidney disease | 0 | 20 | 0 | 20 | 0 | 20 |
| EG002 | Folic Acid and Pentoxifylline Group | 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 combination of Pentoxifylline 400 MG and Folic Acid: drugs used to delay progression of chronic kidney disease | 0 | 20 | 0 | 20 | 0 | 20 |
| EG003 | Control Group | 20 patients will receive their standard therapy only. | 0 | 20 | 0 | 20 | 0 | 20 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 | Heterocyclic Compounds |
| D013805 | Theobromine |
| D014970 | Xanthines |
| D011688 | Purinones |
| D011687 | Purines |
| Male |
|