Effect of Pentoxifylline on Anemia in Hemodialysis Patients

Sponsor

Alexandria University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05708248

Collaborator

(none)

Enrollment

Location

Arms

4.9

Anticipated Duration (Months)

16.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hemodialysis Complication	Drug: pentoxifylline	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group I	Drug: pentoxifylline 400 mg pentoxifylline tablets twice daily with meals for 6 months
No Intervention: Group II

Arm

Intervention/Treatment

Experimental: Group I

Drug: pentoxifylline

400 mg pentoxifylline tablets twice daily with meals for 6 months

No Intervention: Group II

Outcome Measures

Primary Outcome Measures

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

Variation in different inflammatory markers levels [6 months]
Including levels of C-reactive protein (CRP) and Interleukin 6 (IL-6)
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mansoura University Hospital	Mansoura		Egypt

Sponsors and Collaborators

Alexandria University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

hadeer zakaria, PhD student in Clinical Pharmacy and Pharmacy Practice Department, Alexandria University

ClinicalTrials.gov Identifier:

NCT05708248

Other Study ID Numbers:

MDP.22.10.111

First Posted:

Feb 1, 2023

Last Update Posted:

Feb 6, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Anemia

Pentoxifylline

Study Results

No Results Posted as of Feb 6, 2023