Does Oral Pentoxifylline Administration Improve Hemoglobin in Hemodialysis Patients?

Phase 2

Completed

• Conditions: Anemia of Chronic Kidney Disease
• Interventions: Drug: Pentoxifylline

• Registration Number: NCT03731741
• Lead Sponsor: Tanta University

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.

Study Timeline

• Study Start: 2017-11-01
• Primary Completion: 2018-05-03
• Study Completion: 2018-05-04
• Status Verified: 2018-11
• Study First Submitted: 2018-11-02
• Study First Submitted QC: 2018-11-03
• Study First Posted: 2018-11-06
• Last Update Submitted: 2018-11-06
• Last Update Posted: 2018-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treatment group	Pentoxifylline	Group I: 29 patients (25 completed the study) that received the study agent (400mg of oral pentoxifylline daily for 6 months.), besides the appropriate weight-based dose of ESA (60-150I.U/kg/wk).

Primary Outcome Measures

Name	Time	Method
hemoglobin difference	after 6 months from the start	the difference in haemoglobin concentration between the pentoxifylline and control group at the end of the 6 months study period.

Secondary Outcome Measures

Name	Time	Method
difference in inflammatory markers	after 6 months from the start	Difference in CRP and albumin levels between the two groups

Trial Locations

Locations (1)

Tanta university hospital; 🇪🇬 Tanta, Egypt