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Effect of Pentoxifylline on Anemia in Hemodialysis Patients

A

Alexandria University

Status

Not yet enrolling

Conditions

Hemodialysis Complication

Treatments

Drug: pentoxifylline

Study type

Interventional

Funder types

Other

Identifiers

NCT05708248
MDP.22.10.111

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

80 participants in 2 patient groups

Group I
Experimental group
Treatment:
Drug: pentoxifylline
Group II
No Intervention group

Trial contacts and locations

1

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Central trial contact

Hadeer Zakaria

Data sourced from clinicaltrials.gov

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