Pentoxifylline Administration in Hemodialysis Patients

Ain Shams University

Status and phase: Unknown; Early Phase 1

Conditions: Anemia Renal

Treatments: Drug: Trental 400 MG Extended Release Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03800433

pentoxifylline in hemodialysis

Details and patient eligibility

About

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

Full 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).

Enrollment: 46 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

control

No Intervention group

Description:

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

test

Experimental group

Description:

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.

Treatment:

Drug: Trental 400 MG Extended Release Oral Tablet