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The primary goal of this clinical trial is to evaluate the promoting effect of pentoxifylline on anemia correction in hemodialysis patients, and involvement of the hypoxia-inducible factor-2 alpha. While, the secondary aim is to evaluate the effect of pentoxifylline on inflammation, hepcidin and other markers of iron homeostasis in these patients. Participants in this trial will be selected to be age and sex ratio matched and will be randomly assigned into two groups. Patients in group I will receive their regular doses of erythropoietin stimulating agents and other routine treatments plus 400 mg pentoxifylline tablets twice daily with meals for 6 months. While, patients in group II will receive their regular doses of erythropoietin stimulating agents and other routine treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | Experimental |
| |
| Group II | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pentoxifylline | Drug | 400 mg pentoxifylline tablets twice daily with meals for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Variation in Hemoglobin (Hb) levels | 6 months | |
| Variation in Hypoxia inducible factor-2 alpha (HIF-2α) levels | 6 months | |
| Variation in Transforming growth factor β1 (TGF-β1) levels | 6 months | |
| Variation in erythropoietin stimulating agents' (ESAs) doses | 6 months | |
| Variation in ESA resistance index (ESA Dose/kg/Week/Hb) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Variation in different inflammatory markers levels | Including levels of C-reactive protein (CRP) and Interleukin 6 (IL-6) | 6 months |
| Variation in hepcidin hormone levels | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hadeer Zakaria | Contact | +201067030115 | dr.hadeer_2013@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura University Hospital | Al Mansurah | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39499142 | Derived | Zakaria H, Hamdy NA, Sayed-Ahmed NA, El-Mallah A. Pentoxifylline improves anemia through its novel effect on hypoxia-inducible factor-2 alpha in hemodialysis patients: a randomized, double-blind, placebo-controlled clinical trial. Postgrad Med. 2024 Nov;136(8):847-854. doi: 10.1080/00325481.2024.2426448. Epub 2024 Nov 10. |
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| ID | Term |
|---|---|
| D010431 | Pentoxifylline |
| ID | Term |
|---|---|
| D013805 | Theobromine |
| D014970 | Xanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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| Variation in different parameters for iron status evaluation | Including serum levels of ferritin, iron and total iron binding capacity (TIBC) | 6 months |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |