Comparing the Effectiveness and Safety of PDpoetin and cinapoetin in the Remodeling of Anemia in Children with Chronic Renal Failure

Comparison of the effectiveness and safety between Alpha chain Erythropoietin and Beta chain Erythropoietin produced by Iran in the Remodeling of Anemia in Children with Chronic kidney disease

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180222038824N1

Enrollment

Registered

2018-06-05

Start date

2018-02-24

Completion date

Unknown

Last updated

2018-07-16

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

Conditions

alpha and Betha erythropoietin, Anemia in CKD. Chronic kidney disease, stage 3 (moderate)

Interventions

Intervention 1: Intervention group 1:The patient with CKD and anemia in children Up to 18 years old, Number: 20 patients, drug: alpha chain Epoietin, Dosage: 100 unit/kg, interval: 1-3 dose per week,

Eligibility

Sex/Gender

All

Age

3 Months to 18 Years

Inclusion criteria

Inclusion criteria: Parent consent for Research, Children With under 18 years old, children with hemoglobin less than 11 gr/dl, Renal failure with Grade 3-5 ,if that treatment with iron and folic acid and vitamin B12 have not modify the anemia,

Exclusion criteria

Exclusion criteria: No consent of parents Secondary anemia due to causes other than CKD advanced liver disease Uncontrolled hyperparathyroidism Heart failure (New York Heart Association (NYHA) class III and IV) Discoagulopathy Thrombocytopenia leukopenia Acute or chronic bleeding during the last two month ago Systemic or inflammatory infection Major surgery during the last 6 months ago (except surgery for vessels access ) Immune suppressive treatment History of malignancy severe drug hypersensitivity Every reception of blood during the last 3 months ago Every primary blood disorder (Myelodysplasia syndrome, Myeloma, Sickle cell anemia, Malignancy, Multiple Myeloma) Documented resistance to rHuEPO

Design outcomes

Primary

Measure	Time frame
The improve of hemoglobin concentration due to erythropoietin therapy. Timepoint: at the start of study and then every one month in a period of 3 months. Method of measurement: CBC.	—

Secondary

Measure	Time frame
Compare the rate of pain, hypertension, thrombosis, other side effects. Timepoint: six months. Method of measurement: pain sacle, measure BP, physical exam.;Comparing the dose of drug to correct anemia and maintain HB. Timepoint: six months. Method of measurement: dose calculation per kg/wk.;Comparing the Serum electrolytes level between two group. Timepoint: monthly to six months. Method of measurement: K, ca, Ph, PTH level.	—

Measure

Time frame

Compare the rate of pain, hypertension, thrombosis, other side effects. Timepoint: six months. Method of measurement: pain sacle, measure BP, physical exam.;Comparing the dose of drug to correct anemia and maintain HB. Timepoint: six months. Method of measurement: dose calculation per kg/wk.;Comparing the Serum electrolytes level between two group. Timepoint: monthly to six months. Method of measurement: K, ca, Ph, PTH level.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohsen Fathi

Iran University of Medical Sciences

dr.fathi51@gmail.com+98 21 2304 6253

Outcome results

None listed

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