Pentoxifylline Administration in Hemodialysis Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-31

Study Completion Date

2020-04-30

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

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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).

Conditions

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Anemia Renal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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control

23 patients will receive their usual dose of erythropoietin stimulating agents and their routine treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

test

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.

Group Type EXPERIMENTAL

Trental 400 MG Extended Release Oral Tablet

Intervention Type DRUG

oral tablets

Interventions

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Trental 400 MG Extended Release Oral Tablet

oral tablets

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No