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

Investigation of the safety and efficacy of Epolyrec on ESRD patients on hemodialysis and comparison with EPREX

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014120120172N1
Enrollment
160
Registered
2015-02-11
Start date
2015-03-21
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ESRD patients on hemodialysis. Chronic kidney disease, stage 5

Interventions

Intervention 1: In Children 500 Unit/kg/week subcutaneous injection after hemodialysis for 3 months. Intervention 2: Subcutaneous injection after dialysis 80 IU/kg/w for 3 months.
Treatment - Drugs
In Children 500 Unit/kg/week subcutaneous injection after hemodialysis for 3 months
Subcutaneous injection after dialysis 80 IU/kg/w for 3 months

Sponsors

Notarkib Biopharmaceutical Co.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
10 Years to 60 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Younes Panahi

Baghiatalah Hospital

yunespanahi@yahoo.com+98 21 8248 2502

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026