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Does Oral Pentoxifylline Administration Improve Hemoglobin in Hemodialysis Patients?

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EstadoTerminado
Patrocinadores
Tanta University

Palabras clave

Abstracto

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.

Descripción

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.

fechas

Verificado por última vez: 10/31/2018
Primero enviado: 11/01/2018
Inscripción estimada enviada: 11/02/2018
Publicado por primera vez: 11/05/2018
Última actualización enviada: 11/05/2018
Última actualización publicada: 11/07/2018
Fecha de inicio real del estudio: 10/31/2017
Fecha estimada de finalización primaria: 05/02/2018
Fecha estimada de finalización del estudio: 05/03/2018

Condición o enfermedad

Anemia of Chronic Kidney Disease

Intervención / tratamiento

Drug: treatment group

Fase

Fase 2

Grupos de brazos

BrazoIntervención / tratamiento
Experimental: treatment group
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).
Drug: treatment group
a known drug of xanthine derivatives used in intermittent claudication
No Intervention: control group
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.

Criterio de elegibilidad

Edades elegibles para estudiar 18 Years A 18 Years
Sexos elegibles para estudiarAll
Acepta voluntarios saludablessi
Criterios

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.

Salir

Medidas de resultado primarias

1. 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.

Medidas de resultado secundarias

1. difference in inflammatory markers [after 6 months from the start]

Difference in CRP and albumin levels between the two groups

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