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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03480178
Other study ID # 17100366
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 2019
Est. completion date May 2019

Study information

Verified date December 2018
Source Assiut University
Contact zaher alwi, master
Phone 01020361266
Email binalwi2009@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1
Est. completion date May 2019
Est. primary completion date January 2019
Accepts healthy volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

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

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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary Renal anemia refractory to erythropoietin 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
1 months
Secondary Renal anemia refractory to erythropoietin 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
6MONTHS
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