Iranian Journal of Pathology

Hemoglobin And Hematocrit Rise In End-Stage Renal Disease (ESRD) With PDpoetin: Results Of A Phase Ш, Multicenter Clinical Trial

Document Type : Original Research

Authors

Reza Afshar 1
Suzan Sanavi 1
Abbas Kebryaeezadeh 2
Mohsen Naiebpoor 2
Mahboob Lesanpezeshki 3
Mohammad-Reza Khatami 3
Effat Razeghi 3

1 Dept. of Nephrology, School of Medicine, Shahed University, Tehran, Iran.

2 Dept. of Pharmacology, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran

3 Dept. of Nephrology, Tehran University of Medical Sciences, Tehran, Iran

Abstract
  Background and Objective: The anemia of ESRD is a complex disorder, associated with serious complications, which increases patients’ mortality and morbidity. Treatment of this anemia with recombinant human erythropoietin (rh-EPO) is well established. This clinical trial study was conducted within 20 months, from May 2005 to December 2006, in order to evaluate the efficacy of PDpoetin (rh-EPO alpha manufactured in Iran) in anemia correction of hemodialysis patients. Materials and Methods: The study population was composed of 80 patients, aged 22-84 years (with a mean of 49.5 ± 17.5 years), who were 60% male and 40% female. Data were collected by using a questionnaire and a consent form is signed by each patient. All data analysis was carried out using SPSS software and statistical t-test. We administered 80-120 U/kg (up to 300 U/kg in resistant cases) of PDpoetin, 3 times per week, subcutaneously. Then, we followed patients by weekly blood sampling for Hct and Hgb measurement. Results: PDpoetin raised Hct>1% and Hgb>0.3 g/dl per week in 81% and 79% of patients with CRPConclusion: PDpoetin may be an appropriate substitute for imported rh-EPOs. Further research studies are recommended.  

Keywords

Anemia
Erythropoietin
End-Stage Kidney Disease
hemoglobin
Iranian Journal of Pathology
Volume 3, Issue 3 - Serial Number 3
Summer 2008
Pages 157-160

  • Receive Date 29 September 2014

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