Pentoxifylline Administration in Hemodialysis Patients

• Status: Unknown status
• Trial end date: 2020-04-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams University
• Treatments: Epoetin Alfa; Pentoxifylline

Criteria

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.