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

Phase 3
Completed
Conditions
alpha and Betha erythropoietin, Anemia in CKD.
Chronic kidney disease, stage 3 (moderate)
Registration Number
IRCT20180222038824N1
Lead Sponsor
Iran University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
40
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

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

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
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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