Does Oral Pentoxifylline Administration Improve Hemoglobin in Hemodialysis Patients?

Tanta University

Status and phase: Completed; Phase 2

Conditions: Anemia of Chronic Kidney Disease

Treatments: Drug: Pentoxifylline

Study type: Interventional

Funder types: Other

Identifiers

NCT03731741

pentoxifylline in inflammation

Details and patient eligibility

About

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.

Full 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.

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

57 participants in 2 patient groups

treatment group

Experimental group

Description:

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).

Treatment:

Drug: Pentoxifylline

control group

No Intervention group

Description:

Group II: 28 patients (25 completed the study) who did not receive pentoxifylline but they received the appropriate dose of ESA. They were used as a control group and compared to group1 concerning the primary and the secondary outcomes.