CClinicalTrials.gg
Status unknownNCT05708248Updated Feb 6, 2023

Effect of Pentoxifylline on Anemia in Hemodialysis Patients

An interventional study of pentoxifylline in Hemodialysis Complication, sponsored by Alexandria University. Status unknown at 1 site in Egypt. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2023-02-06.

Sponsored by Alexandria University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study summary

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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Conditions studied

  • Hemodialysis Complication

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03

In context

Anemia

1,733 studies on the registry are indexed under Anemia; 246 are open to participants now.

This study's planned enrollment of 80 is below the median of 94 across 1,291 interventional studies indexed under Anemia.

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Lead sponsor

Alexandria University is the lead sponsor of 569 studies on the registry; 125 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Group I

    Drug: pentoxifylline

  • No intervention
    Group II

Interventions

  • Drugpentoxifylline

    400 mg pentoxifylline tablets twice daily with meals for 6 months

06

What researchers measure

Primary outcomes

  1. Variation in Hemoglobin (Hb) levels

    Time frame: 6 months

  2. Variation in Hypoxia inducible factor-2 alpha (HIF-2α) levels

    Time frame: 6 months

  3. Variation in Transforming growth factor β1 (TGF-β1) levels

    Time frame: 6 months

  4. Variation in erythropoietin stimulating agents' (ESAs) doses

    Time frame: 6 months

  5. Variation in ESA resistance index (ESA Dose/kg/Week/Hb)

    Time frame: 6 months

Secondary outcomes

  1. Variation in different inflammatory markers levels

    Including levels of C-reactive protein (CRP) and Interleukin 6 (IL-6)

    Time frame: 6 months

  2. Variation in hepcidin hormone levels

    Time frame: 6 months

  3. Variation in different parameters for iron status evaluation

    Including serum levels of ferritin, iron and total iron binding capacity (TIBC)

    Time frame: 6 months

07

Study locations

1 site
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05708248
Lead sponsor
Alexandria University
Responsible party
hadeer zakaria (PhD student in Clinical Pharmacy and Pharmacy Practice Department, Alexandria University) — Principal investigator
First posted
Feb 1, 2023
Start date
Feb 2023 (estimated)
Primary completion
Jul 2023 (estimated)
Completion
Jul 2023 (estimated)
Last update
Feb 6, 2023

Study contacts

Hadeer Zakaria
Contact
dr.hadeer_2013@yahoo.com
+201067030115

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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