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Does Oral Pentoxifylline Administration Improve Hemoglobin in Hemodialysis Patients?

Effect of Pentoxifylline Administration on Hemoglobin Level of Hemodialysis Patients

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03731741
Enrollment
57
Registered
2018-11-06
Start date
2017-11-01
Completion date
2018-05-04
Last updated
2018-11-08

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

Conditions

Anemia of Chronic Kidney Disease

Brief summary

Our study investigated the effect of using a known drug used in intermittent claudication (named pentoxifylline) as an adjuvant to erythropoietin stimulating agents to improve anemia of hemodialysis patients.

Detailed description

Fifty out of 57 hemodialysis anemic patients were finally included. They were assigned to two groups of equal numbers. Oral Pentoxifylline 400mg once daily was added to the treatment group which was compared to the control group over a six months period regarding hemoglobin, hematocrit, serum albumin and CRP. Inclusion criteria: (Patients with ESRD on HD who have hemoglobin \<11 g/dl, taking Erythropoietin alfa 4000 -12000 I.U/wk and having a urea reduction ratio \>65%.). There were 57 patients who met the inclusion criteria out of 158 patients. Exclusion criteria: Iron deficiency anemia with transferrin saturation \<30%, intact PTH\>300pg/ml, vitamin B12 or folate deficiency (evidenced by macrocytosis), history of intolerance to pentoxifylline or other xanthine derivatives, recent retinal or cerebral hemorrhage or active peptic ulcer disease, pregnancy or breastfeeding, presence of systemic hematological disease or known hemoglobinopathy, major surgery, infection, acute myocardial infarction, or malignancy within the last three months and patients who refused to participate in the study.

Interventions

DRUGPentoxifylline

a known drug of xanthine derivatives used in intermittent claudication

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* (Patients with ESRD on HD who have hemoglobin \<11 g/dl, taking Erythropoietin alfa 4000 -12000 I.U/wk and having a urea reduction ratio \>65%.). There were 57 patients who met the inclusion criteria out of 158 patients

Exclusion criteria

* Iron deficiency anemia with transferrin saturation \<30%, intact PTH\>300pg/ml, vitamin B12 or folate deficiency (evidenced by macrocytosis), history of intolerance to pentoxifylline or other xanthine derivatives, recent retinal or cerebral hemorrhage or active peptic ulcer disease, pregnancy or breastfeeding, presence of systemic hematological disease or known hemoglobinopathy, major surgery, infection, acute myocardial infarction, or malignancy within the last three months and patients who refused to participate in the study.

Design outcomes

Primary

MeasureTime frameDescription
hemoglobin differenceafter 6 months from the startthe difference in haemoglobin concentration between the pentoxifylline and control group at the end of the 6 months study period.

Secondary

MeasureTime frameDescription
difference in inflammatory markersafter 6 months from the startDifference in CRP and albumin levels between the two groups

Countries

Egypt

Outcome results

None listed

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