Renal Anemia Refractory to Erythropoietin

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.

Study Overview

• Status: Unknown
• Conditions: 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 Type: Observational
• Enrollment (Anticipated): 1

Contacts and Locations

• Study Contact: Name: zaher alwi, master; Phone Number: 01020361266; Email: binalwi2009@gmail.com
• Study Contact Backup: Name: Mohamed Sabah, prof.; Phone Number: 01069272662; Email: Mohamedabbassobh@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2019
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): May 1, 2019

Study Registration Dates

• First Submitted: February 13, 2018
• First Submitted That Met QC Criteria: March 20, 2018
• First Posted (Actual): March 29, 2018

Study Record Updates

• Last Update Posted (Actual): January 2, 2019
• Last Update Submitted That Met QC Criteria: December 31, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Marrow Diseases; Hematologic Diseases; Myelodysplastic Syndromes; Anemia; Anemia, Refractory
• Other Study ID Numbers: 17100366

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No