Effect of Pentoxifylline on Anemia in Hemodialysis Patients

Not Applicable

Not yet recruiting

• Conditions: Hemodialysis Complication
• Interventions: Drug: pentoxifylline

• Registration Number: NCT05708248
• Lead Sponsor: Alexandria University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-27
• Study First Submitted QC: 2023-01-23
• Status Verified: 2023-02
• Study Start: 2023-02
• Study First Posted: 2023-02-01
• Last Update Submitted: 2023-02-02
• Last Update Posted: 2023-02-06
• Primary Completion: 2023-07
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I	pentoxifylline	-

Primary Outcome Measures

Name	Time	Method
Variation in ESA resistance index (ESA Dose/kg/Week/Hb)	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 Hemoglobin (Hb) levels	6 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mansoura University Hospital; 🇪🇬 Mansoura, Egypt