Pentoxifylline Administration in Hemodialysis Patients

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

Status

UNKNOWN

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03800433

Enrollment

Registered

2019-01-11

Start date

2019-10-31

Completion date

2020-04-30

Last updated

2019-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia Renal

Keywords

pentoxifylline

Brief summary

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

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).

Interventions

DRUGTrental 400 MG Extended Release Oral Tablet

oral tablets

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Contacts

Primary ContactRadwa M Elmetwaly, Bachelor

radwa_mohm@yahoo.com00201065371016

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026