Investigation of the safety and efficacy of Epolyrec in comparrision to Eprex in the management of renal anemia.

Phase 4

Completed

• Conditions: ESRD patients on hemodialysis.; Chronic kidney disease, stage 5

• Registration Number: IRCT2014120120172N1
• Lead Sponsor: otarkib Biopharmaceutical Co.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Inclusion Criteria: End Stage Renal Disease patients who were under hemodialysis and had a Glomerular filtration rate less than14 ml/min/1.73m2 together with a hematocrit less than30% or hemoglobin less than 10g/dl; Presence of Iron store(serum Ferritin) more than100mg/L and transferrin saturationmore than 20%);Patients aged between 10 to 60 years

Exclusion Criteria

CRP more than 10mg/dl; uncontrolled hypertension; Symptomatic ischemic heart disease; History of cerebrovascular event; Graft rejection; Polycystic kidney disease ; Myeloma ; Malignancies

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hemoglobin. Timepoint: Before using medicine and every 2 weeks till end of investigation. Method of measurement: Blood test.;Hematocrit. Timepoint: Before using the medicine and every 2 week till end of investigation. Method of measurement: Blood test.