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Effect of Pentoxifylline on Anemia in Hemodialysis Patients

Primary Purpose

Hemodialysis Complication

Status

Not yet recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

pentoxifylline

About this trial

This is an interventional treatment trial for Hemodialysis Complication

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Mansoura University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group I

Group II

Arm Description

Outcomes

Primary Outcome Measures

Variation in Hemoglobin (Hb) levels

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

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

Variation in erythropoietin stimulating agents' (ESAs) doses

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

Secondary Outcome Measures

Variation in different inflammatory markers levels

Including levels of C-reactive protein (CRP) and Interleukin 6 (IL-6)

Variation in hepcidin hormone levels

Variation in different parameters for iron status evaluation

Including serum levels of ferritin, iron and total iron binding capacity (TIBC)

Full Information

NCT ID

NCT05708248

First Posted

December 27, 2022

Last Updated

February 2, 2023

Sponsor

Alexandria University

1. Study Identification

Unique Protocol Identification Number

NCT05708248

Brief Title

Effect of Pentoxifylline on Anemia in Hemodialysis Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

February 2023 (Anticipated)

Primary Completion Date

July 2023 (Anticipated)

Study Completion Date

July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemodialysis Complication

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group I

Arm Type

Experimental

Arm Title

Group II

Arm Type

No Intervention

Intervention Type

Drug

Intervention Name(s)

pentoxifylline

Intervention Description

400 mg pentoxifylline tablets twice daily with meals for 6 months

Primary Outcome Measure Information:

Title

Variation in Hemoglobin (Hb) levels

Time Frame

6 months

Title

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

Time Frame

6 months

Title

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

Time Frame

6 months

Title

Variation in erythropoietin stimulating agents' (ESAs) doses

Time Frame

6 months

Title

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

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Variation in different inflammatory markers levels

Description

Including levels of C-reactive protein (CRP) and Interleukin 6 (IL-6)

Time Frame

6 months

Title

Variation in hepcidin hormone levels

Time Frame

6 months

Title

Variation in different parameters for iron status evaluation

Description

Including serum levels of ferritin, iron and total iron binding capacity (TIBC)

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hadeer Zakaria

Phone

+201067030115

dr.hadeer_2013@yahoo.com

Facility Information:

Facility Name

Mansoura University Hospital

City

Mansoura

Country

Egypt

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hadeer Zakaria

Phone

01067030115

dr.hadeer_2013@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Effect of Pentoxifylline on Anemia in Hemodialysis Patients

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