Effect of Pentoxifylline on Anemia in Hemodialysis Patients

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Pentoxifylline on Anemia in Hemodialysis Patients: Role of Hypoxia Inducible Factor-2 Alpha

Conditions
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Hemodialysis Complication

Intervention / Treatment
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* Drug: pentoxifylline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both sexes of HD patients Age >20 years Patients who have adequate hemodialysis for at least 6 months Hb level ≤ 10.5 g/dl Exclusion Criteria: Recently dialyzed patients (less than 6 months) Patients with known sensitivity to theophylline or other xanthine derivatives Severe iron deficiency with serum ferritin < 100 µg/dL and/or TSAT < 20% Planning for pregnancy, pregnancy, or lactation Patients with severe liver disease or other organ failure Previous renal transplantation, noncompliance with medication or HD prescription, or inability to oral drug administration Malignancy within last 3 months

Ages Eligible for Study
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Minimum Age: 21 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I<br> | Drug: pentoxifylline<br>* 400 mg pentoxifylline tablets twice daily with meals for 6 months<br>|
| No Intervention: Group II<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Variation in different parameters for iron status evaluation | Including serum levels of ferritin, iron and total iron binding capacity (TIBC) | 6 months |