Effect of Pentoxifylline on Anemia in Hemodialysis Patients

Effect of Pentoxifylline on Anemia in Hemodialysis Patients: Role of Hypoxia Inducible Factor-2 Alpha

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hemodialysis Complication
• Intervention / Treatment: Drug: pentoxifylline

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hadeer Zakaria; Phone Number: +201067030115; Email: dr.hadeer_2013@yahoo.com

Study Locations

• Egypt
  • Mansoura, Egypt
    • Mansoura University Hospital
    • Contact: Hadeer Zakaria; Phone Number: 01067030115; Email: dr.hadeer_2013@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group I	Drug: pentoxifylline; 400 mg pentoxifylline tablets twice daily with meals for 6 months
NO_INTERVENTION: Group II

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variation in different inflammatory markers levels	Including levels of C-reactive protein (CRP) and Interleukin 6 (IL-6)	6 months
Variation in hepcidin hormone levels		6 months
Variation in different parameters for iron status evaluation	Including serum levels of ferritin, iron and total iron binding capacity (TIBC)	6 months

Collaborators and Investigators

• Sponsor: Alexandria University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2023
• Primary Completion (ANTICIPATED): July 1, 2023
• Study Completion (ANTICIPATED): July 1, 2023

Study Registration Dates

• First Submitted: December 27, 2022
• First Submitted That Met QC Criteria: January 23, 2023
• First Posted (ACTUAL): February 1, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2023
• Last Update Submitted That Met QC Criteria: February 2, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Protective Agents; Antioxidants; Phosphodiesterase Inhibitors; Free Radical Scavengers; Radiation-Protective Agents; Pentoxifylline
• Other Study ID Numbers: MDP.22.10.111

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No