The presence trial aimed to evaluate the efficacy of EPOLYREC in the management of renal anemia in End Stage Renal Disease patients on hemodialysis.160 patients(aged between 10-60years) were those with end stage renal disease who were under hemodialysis were assigned to receive EPOLYREC subcutaneously at a dose of 80-100 IU/kg in 2-3 diveded dose after each dialysis session for 3 months. Hemoglobin, hematocrit and CBC/DIFF together with biomarks of iron status, renal function and trace elements were evaluated at baseline and during the course of trial. patients had a Glomerular filtration rate less than14 ml/min/1.73m2 together with a hematocrit less than 30% or hemoglobin less than 10g/dl; Presence of adequate Iron store(serum Ferritin more than 100mg/L and transferrin saturation more than 20%) was also among the inclusion criteria.
Exclusion Criteria were CRP more than 10mg/dl; uncontrolled hypertension; Symptomatic ischemic heart disease; History of cerebrovascular events; Graft rejection; Polycystic kidney disease ; Myeloma ; Malignancies.
This study was a multi-center prospective clinical trial investigating the efficacy of EPOLYREC in the elevation of hemoglobin level and hematocrit in anemic End Stage Renal patients who were under dialysis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014120120172N1
Registration date:2015-02-11, 1393/11/22
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-02-11, 1393/11/22
Registrant information
Name
Maryam Fayazi
Name of organization / entity
Notarkib Biopharmaceutical Company
Country
Iran (Islamic Republic of)
Phone
+98 21 6656 1850
Email address
fayazi@recpharma.com
Recruitment status
Recruitment complete
Funding source
Notarkib Biopharmaceutical Co.
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the safety and efficacy of Epolyrec on ESRD patients on hemodialysis and comparison with EPREX
Public title
Investigation of the safety and efficacy of Epolyrec in comparrision to Eprex in the management of renal anemia.
Purpose
Treatment
Inclusion/Exclusion 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
Age
From 10 years old to 60 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Baghiatalah Hospital
Street address
Baghiatalah Hospital, Molasadra street, Vanak Sq.
City
Tehran
Postal code
Approval date
2012-12-26, 1391/10/06
Ethics committee reference number
صورتجلسه شماره 32
Health conditions studied
1
Description of health condition studied
ESRD patients on hemodialysis
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
hemoglobin
Timepoint
Before using medicine and every 2 weeks till end of investigation
Method of measurement
Blood test
2
Description
Hematocrit
Timepoint
Before using the medicine and every 2 week till end of investigation
Method of measurement
Blood test
Secondary outcomes
empty
Intervention groups
1
Description
In Children 500 Unit/kg/week subcutaneous injection after hemodialysis for 3 months
Category
Treatment - Drugs
2
Description
Subcutaneous injection after dialysis 80 IU/kg/w for
3 months