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The aim of the study is to assess the impact of pentoxifylline administration on the modulation of hyporesponsiveness to erythropoietin stimulating agents in hemodialysis patients
this is a prospective, randomized, controlled study to assess the impact of pentoxifylline administration on the modulation of hyporesponsiveness to erythropoietin stimulating agents in hemodialysis patients by determining several outcomes from the intervention and control groups at the end of the study.These outcomes include;the difference in hemoglobin and hematocrit concentration , the difference in inflammatory markers tumor necrosis factor Alpha (TNF-α), interleukin-1 Beta (IL-1β),the difference in the dosage of erythropoiesis stimulating agents ,and The erythropoietin stimulating agents (ESA) resistance index (ERI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | No Intervention | 23 patients will receive their usual dose of erythropoietin stimulating agents and their routine treatment. | |
| test | Experimental | 23 patients will receive the intervention drug Pentoxifylline (Trental 400 milligram(MG) Extended Release Oral Tablet) twice daily in addition their usual dose of erythropoietin stimulating agents and their routine treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trental 400 MG Extended Release Oral Tablet | Drug | oral tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| The difference in hemoglobin and hematocrit concentration between the intervention and control groups at the end of the study | Patients will be evaluated regularly every month for hemoglobin concentration | up to 6 months post baseline |
| safety & tolerability of pentoxifylline ( frequency of adverse drug effects due to Pentoxifylline as well as compliance with pentoxifylline). | Patients will be evaluated regularly for frequency of adverse drug effects due to Pentoxifylline as well as compliance with pentoxifylline | up to 6 months post baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory markers TNF-a, IL-1β. | patient will be subjected to laboratory evaluation for estimation of IL-1β,TNF-α levels at baseline as well as end of study evaluation | up to 6 months post baseline |
| Difference in the dosage of erythropoiesis stimulating agents. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Radwa M Elmetwaly, Bachelor | Contact | 00201065371016 | radwa_mohm@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Lamia El Wakeel, Ass.Prof | Ass.prof clinical pharmacy | Study Director |
| Radwa El Borolossy, Phd | Lecturer of clinical pharmacy | Study Director |
| Magdy ElSharkawy, Prof.Dr. |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15758012 | Background | Weiss G, Goodnough LT. Anemia of chronic disease. N Engl J Med. 2005 Mar 10;352(10):1011-23. doi: 10.1056/NEJMra041809. No abstract available. | |
| 17635745 | Background | Johnson DW, Pollock CA, Macdougall IC. Erythropoiesis-stimulating agent hyporesponsiveness. Nephrology (Carlton). 2007 Aug;12(4):321-30. doi: 10.1111/j.1440-1797.2007.00810.x. |
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| ID | Term |
|---|---|
| D010431 | Pentoxifylline |
| ID | Term |
|---|---|
| D013805 | Theobromine |
| D014970 | Xanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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the dose of ESA will be assessed at end of study evaluation |
| up to 6 months post baseline |
| The ESA ( erythropoiesis stimulating agents)resistance index (ERI). | ERI will be assessed for patients by determining ESA dose and hemoglobin concentration | up to 6 months post baseline |
| Prof. of nephrology |
| Principal Investigator |
| 15213276 | Background | Cooper A, Mikhail A, Lethbridge MW, Kemeny DM, Macdougall IC. Pentoxifylline improves hemoglobin levels in patients with erythropoietin-resistant anemia in renal failure. J Am Soc Nephrol. 2004 Jul;15(7):1877-82. doi: 10.1097/01.asn.0000131523.17045.56. |
| 20470305 | Background | Ferrari P, Mallon D, Trinder D, Olynyk JK. Pentoxifylline improves haemoglobin and interleukin-6 levels in chronic kidney disease. Nephrology (Carlton). 2010 Apr;15(3):344-9. doi: 10.1111/j.1440-1797.2009.01203.x. |
| 22241639 | Background | Goicoechea M, Garcia de Vinuesa S, Quiroga B, Verdalles U, Barraca D, Yuste C, Panizo N, Verde E, Munoz MA, Luno J. Effects of pentoxifylline on inflammatory parameters in chronic kidney disease patients: a randomized trial. J Nephrol. 2012 Nov-Dec;25(6):969-75. doi: 10.5301/jn.5000077. |
| 26023017 | Background | Ogawa T, Nitta K. Erythropoiesis-stimulating agent hyporesponsiveness in end-stage renal disease patients. Contrib Nephrol. 2015;185:76-86. doi: 10.1159/000380972. Epub 2015 May 19. |
| 28487874 | Background | Shahbazian H, Ghorbani A, Zafar-Mohtashami A, Balali A, AleAli A, Lashkarara GR. Administration of pentoxifylline to improve anemia of hemodialysis patients. J Renal Inj Prev. 2016 Nov 26;6(1):61-64. doi: 10.15171/jrip.2017.11. eCollection 2017. |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |