Effect of Pentoxifylline on Anemia 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

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-28

Study Completion Date

2023-07-31

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.

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Detailed Description

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Conditions

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Hemodialysis Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group I

Group Type EXPERIMENTAL

pentoxifylline

Intervention Type DRUG

400 mg pentoxifylline tablets twice daily with meals for 6 months

Group II

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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pentoxifylline

400 mg pentoxifylline tablets twice daily with meals for 6 months

Intervention Type DRUG

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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No