Effect of Pentoxifylline on Anemia in Hemodialysis Patients

NCT05708248 | Unknown

• 1 other identifier: MDP.22.10.111
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hemodialysis Complication

Outcome Measures

Primary Outcomes (5)

• Variation in Hemoglobin (Hb) levels

  6 months

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

  6 months

• Variation in Transforming growth factor β1 (TGF-β1) levels

  6 months

• Variation in erythropoietin stimulating agents' (ESAs) doses

  6 months

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

  6 months

Secondary Outcomes (3)

• Variation in different inflammatory markers levels

  6 months

• Variation in hepcidin hormone levels

  6 months

• Variation in different parameters for iron status evaluation

  6 months

Study Arms (2)

Group I

EXPERIMENTAL

Drug: pentoxifylline

Group II

NO INTERVENTION

Interventions

pentoxifylline DRUG

400 mg pentoxifylline tablets twice daily with meals for 6 months

Group I

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both sexes of HD patients
• Age \>20 years
• Patients who have adequate hemodialysis for at least 6 months
• Hb level ≤ 10.5 g/dl

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Mansoura University Hospital

Al Mansurah, Egypt

Location

Related Publications (1)

• Zakaria H, Hamdy NA, Sayed-Ahmed NA, El-Mallah A. Pentoxifylline improves anemia through its novel effect on hypoxia-inducible factor-2 alpha in hemodialysis patients: a randomized, double-blind, placebo-controlled clinical trial. Postgrad Med. 2024 Nov;136(8):847-854. doi: 10.1080/00325481.2024.2426448. Epub 2024 Nov 10.

  PMID: 39499142 DERIVED

MeSH Terms

Interventions

Pentoxifylline

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Hadeer Zakaria

CONTACT

+201067030115; dr.hadeer_2013@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student in Clinical Pharmacy and Pharmacy Practice Department

Study Record Dates

• First Submitted: December 27, 2022
• First Posted: February 1, 2023
• Study Start: February 1, 2023
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: February 6, 2023

Record last verified: 2023-02

Locations

EG (1)