A Retrospective Study of the Efficacy and Safety of Hema-Plus (Recombinant Human Erythropoietin Alfa) in Patients with Chronic Kidney Disease who continuously used Hema-Plus at Siriraj Hospital

Phase 4

Active, not recruiting

• Conditions: - Pure Red Cell Aplasia (PRCA)- Thrombotic vascular event (TVE)- Seizure- Hypersensitivity- Hypertension; Pure Red Cell Aplasia (PRCA); Thrombotic vascular event (TVE); Seizure; Hypersensitivity

• Registration Number: TCTR20170808001
• Lead Sponsor: Apexcela Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-08
• Study Completion: 2017-10-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Each patient included in the review must meet all of the following criteria to be in this study:
1.Presented with chronic kidney disease
2.History of receiving Hema-Plus for at least 6 months during the study period

Exclusion Criteria

1.Subjects who met inclusion criteria but their medical records are not available for access.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean hemoglobin values After treating with study drug Hemoglobin value,Adverse events After treating with study drug Adverse events,Proportion of patient achieving target hemoglobin value of 11-12 g/dL After treating with study drug Number of patient who achieved target hemoglobin,Mean difference between base line hemoglobin and follow up hemoglobin Before and after treating with study drug Hemoglobin value

Secondary Outcome Measures

Name	Time	Method
A NA NA