Renal Anemia Refractory to Erythropoietin

• Conditions: Renal Anemia; ESRD

• Registration Number: NCT03480178
• Lead Sponsor: Assiut University

Brief Summary

This study evaluates the renal anemia refractory to Epo . in hemodialysis patients. all of participants will receive Epo. and identify various factors contributing to etiology of renal anemia in Epo- resistant patients.

Detailed Description

Chronic kidney disease (CKD) is considered a public health problem worldwide with high incidence and prevalence rates.Anemia is one of the most frequent early complication of CKD. The main cause is erythropoietin (EPO) deficiency due to impaired kidney function However, other causes should be considered when the severity of anemia is inconsistent with the decrease in renal function; when there is evidence of iron deficiency or matching decreases in hemoglobin, leukopenia and/or thrombocytopenia are also found

Study Timeline

• Study First Submitted: 2018-02-13
• Study First Submitted QC: 2018-03-20
• Study First Posted: 2018-03-29
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-31
• Study Start: 2019-01
• Primary Completion: 2019-01
• Last Update Posted: 2019-01-02
• Study Completion: 2019-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Patients greater than or equal to 18 years old with CKD on hemodialysis

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Exclusion Criteria

1. • Evidence of infections especial of vascular access .
2. • malnutrition and manifestation of iron, B12, folate and protein deficiency .

3. • any underling cause as;

   • Hematologic malignances -Hemolytic anemia -
   • Aplastic anemia (infection and/or bleeding with anemia)
   • Solid tumors
   • Bleeding (skin ,mucosal ,orificial)
   • Evidence of mineral bone disease (CKD-MBD)
   • Others

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Renal anemia refractory to erythropoietin	1 months	1 .Measurement of Hemoglobin , feritin and reitculocyte of patient before treatmeant by Epo. 100IU per Kg per week-SC.; 2- Assessment to measure of hemoglobin of patient after treatment

Secondary Outcome Measures

Name	Time	Method
Renal anemia refractory to erythropoietin	6MONTHS	1 .Measurement of Hemoglobin of patient by CBC before treatmeant by Epo. 100IU per Kg per week-SC?; 2- Assessment to hemoglobin of anemic patient during the specified post -dose period ,6months