Status:
UNKNOWN
Pentoxifylline Administration in Hemodialysis Patients
Lead Sponsor:
Ain Shams University
Conditions:
Anemia Renal
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2020
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT03800433
Start Date
October 1 2019
End Date
April 1 2020
Last Update
September 25 2019
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