Pentoxifylline Administration in Hemodialysis Patients

Early Phase 1

• Conditions: Anemia Renal
• Interventions: Drug: Trental 400 MG Extended Release Oral Tablet

• Registration Number: NCT03800433
• Lead Sponsor: Ain Shams University

Brief Summary

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

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).

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2019-01-09
• Study First Submitted QC: 2019-01-10
• Study First Posted: 2019-01-11
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-24
• Last Update Posted: 2019-09-25
• Study Start: 2019-10
• Primary Completion: 2020-04
• Study Completion: 2020-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 46

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
test	Trental 400 MG Extended Release Oral Tablet	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.

Primary Outcome Measures

Name	Time	Method
safety & tolerability of pentoxifylline ( frequency of adverse drug effects due to Pentoxifylline as well as compliance with pentoxifylline).	up to 6 months post baseline	Patients will be evaluated regularly for frequency of adverse drug effects due to Pentoxifylline as well as compliance with pentoxifylline
The difference in hemoglobin and hematocrit concentration between the intervention and control groups at the end of the study	up to 6 months post baseline	Patients will be evaluated regularly every month for hemoglobin concentration

Secondary Outcome Measures

Name	Time	Method
Difference in the dosage of erythropoiesis stimulating agents.	up to 6 months post baseline	the dose of ESA will be assessed at end of study evaluation
The ESA ( erythropoiesis stimulating agents)resistance index (ERI).	up to 6 months post baseline	ERI will be assessed for patients by determining ESA dose and hemoglobin concentration
Inflammatory markers TNF-a, IL-1β.	up to 6 months post baseline	patient will be subjected to laboratory evaluation for estimation of IL-1β,TNF-α levels at baseline as well as end of study evaluation