Effect of Roxadustat in management of anemia and iron regulation in cirrhosis of liver patients

Phase 2

Completed

• Conditions: Cirrhosis of liver patients who is anemic; Anemia, Cirrhosis of Liver, Treatment with Roxadustat a hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitor

• Registration Number: TCTR20230615001
• Lead Sponsor: Bangabandhu Sheikh Mujib Medical University

Brief Summary

This is a randomized controlled trial conducted to evaluate the effect of roxadustat in increasing haemoglobin level and in iron regulation through decreasing hepcidin level with anemia in liver cirrhosis patients. In roxadustat treatment group, hemoglobin level and erythropoetin level increased and hepcidin level decreased after 6 weeks and these changes were statistically significant when compared with the changes of standard medical care group.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-15
• Study Completion: 2024-03-02
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

1. Patients with cirrhosis of liver (Child pugh A or B) 2. Anemia. 3. Age: More than 18 years

Exclusion Criteria

1. Patients with Child Pugh C liver cirrhosis 2. Hepatocellular carcinoma 3. Pregnancy or lactation 4. Active variceal bleeding 5. Adult polycystic kidney disease 6. Hypo/Hyperthyroidism 7. Systemic Hypertension 8. Hyperkalemia 9. Patient with co-morbid condition (COPD, CKD, CCF, MI etc.)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hemoglobin level 6 weeks hematology analyzer

Secondary Outcome Measures

Name	Time	Method
serum hepcidin level 6 weeks ELISA,Serum Erythropoetin (EPO) level 6 weeks ELISA