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Renal Anemia Refractory to Erythropoietin

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ClinicalTrials.gov Identifier: NCT03480178
Recruitment Status : Unknown
Verified December 2018 by zaher alwi hadi, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : March 29, 2018
Last Update Posted : January 2, 2019
Sponsor:
Information provided by (Responsible Party):
zaher alwi hadi, Assiut University

Study Description
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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.

Condition or disease
ESRD Renal Anemia

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 Design
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Study Type : Observational
Estimated Enrollment : 1 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Renal Anemia Refractory to Erythropoietin
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Renal anemia refractory to erythropoietin [ Time Frame: 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 :
  1. Renal anemia refractory to erythropoietin [ Time Frame: 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



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
  1. The investigators choose 50 uraemic patients on hemodialysis randomly and receiving Epo.among those admitted to nephrology ward and out Patient clinic of the department of internal medicine of Assiut University Hospital.
  2. Follow up of patients for 6 months with CBC every month.
  3. Searching for number of patients among this 50 who have failure to correct the anemia with Epo. (100IU /Kg / week- SC ) For target HB 11 gm.
  4. Effect of bleeding, infection and malnutrition.
  5. Scaring for the possible underling cause of anemia refractory to Epo. Clinically, laboratory at the end of study period.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03480178


Contacts
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Contact: zaher alwi, master 01020361266 binalwi2009@gmail.com
Contact: Mohamed Sabah, prof. 01069272662 Mohamedabbassobh@gmail.com

Sponsors and Collaborators
Assiut University
More Information
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Responsible Party: zaher alwi hadi, Assistant Lecturer, Assiut University
ClinicalTrials.gov Identifier: NCT03480178    
Other Study ID Numbers: 17100366
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: January 2, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anemia
Anemia, Refractory
Hematologic Diseases
Myelodysplastic Syndromes
Bone Marrow Diseases