Pentoxifylline Administration in Hemodialysis Patients

September 24, 2019 updated by: Radwa Mohamed Elmetwaly, Ain Shams University

Impact of Pentoxifylline Administration on the Modulation of Hyporesponsiveness to Erythropoietin Stimulating Agents in Hemodialysis Patients

The aim of the study is to assess the impact of pentoxifylline administration on the modulation of hyporesponsiveness to erythropoietin stimulating agents in hemodialysis patients

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

this is a prospective, randomized, controlled study to assess the impact of pentoxifylline administration on the modulation of hyporesponsiveness to erythropoietin stimulating agents in hemodialysis patients by determining several outcomes from the intervention and control groups at the end of the study.These outcomes include;the difference in hemoglobin and hematocrit concentration , the difference in inflammatory markers tumor necrosis factor Alpha (TNF-α), interleukin-1 Beta (IL-1β),the difference in the dosage of erythropoiesis stimulating agents ,and The erythropoietin stimulating agents (ESA) resistance index (ERI).

Study Type

Interventional

Enrollment (Anticipated)

46

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults (18 years or over).
  • Stable hemodialysis >6 months.
  • Regular haemodialysis (3 times/ week).
  • ESA resistant anemia (Hb <10 mg/dl for 6 mo.).
  • ESA dose of >8000 IU/wk.

Exclusion Criteria:

  • Inadequate hemodialysis.
  • Hyperparathyroidism (PTH>800 pg/l).
  • Known hypersensitivity to, or intolerance of Pentoxifylline.
  • Absolute or functional iron deficiency (ferritin < 100 μg/L and/or transferrin saturation < 20%).
  • Presence of systemic haematological disease (including antibody-mediated pure red cell aplasia) or known haemoglobinopathy.
  • Major surgery, infection, inflammatory diseases, acute myocardial infarction or malignancy within the last 3 months.
  • Patients with chronic liver disease and patients who had received immunosuppressive therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
23 patients will receive their usual dose of erythropoietin stimulating agents and their routine treatment.
Experimental: test
23 patients will receive the intervention drug Pentoxifylline (Trental 400 milligram(MG) Extended Release Oral Tablet) twice daily in addition their usual dose of erythropoietin stimulating agents and their routine treatment.
Drug: Trental 400 MG Extended Release Oral Tablet
oral tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The difference in hemoglobin and hematocrit concentration between the intervention and control groups at the end of the study
Time Frame: up to 6 months post baseline
Patients will be evaluated regularly every month for hemoglobin concentration
up to 6 months post baseline
safety & tolerability of pentoxifylline ( frequency of adverse drug effects due to Pentoxifylline as well as compliance with pentoxifylline).
Time Frame: up to 6 months post baseline
Patients will be evaluated regularly for frequency of adverse drug effects due to Pentoxifylline as well as compliance with pentoxifylline
up to 6 months post baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammatory markers TNF-a, IL-1β.
Time Frame: up to 6 months post baseline
patient will be subjected to laboratory evaluation for estimation of IL-1β,TNF-α levels at baseline as well as end of study evaluation
up to 6 months post baseline
Difference in the dosage of erythropoiesis stimulating agents.
Time Frame: up to 6 months post baseline
the dose of ESA will be assessed at end of study evaluation
up to 6 months post baseline
The ESA ( erythropoiesis stimulating agents)resistance index (ERI).
Time Frame: up to 6 months post baseline
ERI will be assessed for patients by determining ESA dose and hemoglobin concentration
up to 6 months post baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Director: Lamia El Wakeel, Ass.Prof, Ass.prof clinical pharmacy
  • Study Director: Radwa El Borolossy, Phd, Lecturer of clinical pharmacy
  • Principal Investigator: Magdy ElSharkawy, Prof.Dr., Prof. of nephrology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2019

Primary Completion (Anticipated)

April 1, 2020

Study Completion (Anticipated)

April 1, 2020

Study Registration Dates

First Submitted

January 9, 2019

First Submitted That Met QC Criteria

January 10, 2019

First Posted (Actual)

January 11, 2019

Study Record Updates

Last Update Posted (Actual)

September 25, 2019

Last Update Submitted That Met QC Criteria

September 24, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pentoxifylline in hemodialysis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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