Pentoxifylline Administration in Hemodialysis Patients

Study Overview
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Brief Summary
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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

Detailed Description
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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).

Official Title
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Impact of Pentoxifylline Administration on the Modulation of Hyporesponsiveness to Erythropoietin Stimulating Agents in Hemodialysis Patients

Conditions
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Anemia Renal

Intervention / Treatment
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* Drug: Trental 400 MG Extended Release Oral Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (18 years or over). Stable hemodialysis >6 months. Regular haemodialysis (3 times/ week). ESA resistant anemia (Hb <10 mg/dl for 6 mo.). ESA dose of >8000 IU/wk. Exclusion Criteria: Inadequate hemodialysis. Hyperparathyroidism (PTH>800 pg/l). Known hypersensitivity to, or intolerance of Pentoxifylline. Absolute or functional iron deficiency (ferritin < 100 μg/L and/or transferrin saturation < 20%). Presence of systemic haematological disease (including antibody-mediated pure red cell aplasia) or known haemoglobinopathy. Major surgery, infection, inflammatory diseases, acute myocardial infarction or malignancy within the last 3 months. Patients with chronic liver disease and patients who had received immunosuppressive therapy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br>23 patients will receive their usual dose of erythropoietin stimulating agents and their routine treatment. | |
| Experimental: test<br>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. | Drug: Trental 400 MG Extended Release Oral Tablet<br>* oral tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pentoxifylline