Effect of Pentoxifylline on Anemia in Hemodialysis Patients

Hemodialysis Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05708248
• Other study ID #: MDP.22.10.111
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2023
• Est. completion date: July 2023

Study information

• Verified date: February 2023
• Source: Alexandria University
• Contact: Hadeer Zakaria
• Phone: +201067030115
• Email: dr.hadeer_2013[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: July 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Hemodialysis Complication

Intervention

Drug:
• pentoxifylline
400 mg pentoxifylline tablets twice daily with meals for 6 months

Locations

Country	Name	City	State
Egypt	Mansoura University Hospital	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation in Hemoglobin (Hb) levels		6 months
Primary	Variation in Hypoxia inducible factor-2 alpha (HIF-2a) levels		6 months
Primary	Variation in Transforming growth factor ß1 (TGF-ß1) levels		6 months
Primary	Variation in erythropoietin stimulating agents' (ESAs) doses		6 months
Primary	Variation in ESA resistance index (ESA Dose/kg/Week/Hb)		6 months
Secondary	Variation in different inflammatory markers levels	Including levels of C-reactive protein (CRP) and Interleukin 6 (IL-6)	6 months
Secondary	Variation in hepcidin hormone levels		6 months
Secondary	Variation in different parameters for iron status evaluation	Including serum levels of ferritin, iron and total iron binding capacity (TIBC)	6 months