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Hydroxyurea and EPO in Sickle Cell Disease — ACHiEvE-SCD  

Sickle Cell Disease Clinical Trial

Official title:
Assessing Combination Hydroxyurea and Exogenous Erythropoietin in Sickle Cell Disease

Clinical Trial Summary

The proposed study is a Phase 1/2 multi-center study evaluating the safety and efficacy of erythropoietin (EPO) in combination with hydroxyurea in the treatment of chronic anemia in patients with sickle cell disease (SCD).

Clinical Trial Description

Sickle cell disease (SCD) is a devastating inherited hemoglobin disorder characterized by recurrent episodes of pain and chronic hemolytic anemia. Chronic anemia contributes to multi-organ damage and decreased life expectancy in SCD. However, there are limited treatment options for anemia in SCD. Erythropoietin (EPO) is the standard of care for treatment of anemia related to chronic kidney disease (CKD) and is also used ad hoc in patients with SCD. However, there is limited data on the safety and efficacy of EPO in patients with SCD, especially in combination with hydroxyurea. Therefore, this study aims to treat patients on stable hydroxyurea therapy with subcutaneous EPO, with the goal of assessing the safety of EPO therapy and its effect on chronic anemia in SCD. (Note: Outcome measure changes were in place prior to study initiation.) ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05451940
Study type Interventional
Source University of Pittsburgh
Contact Nelly K Kiriza, MD, MPH
Phone (412) 246-6009
Email nkk18@pitt.edu
Status Recruiting
Phase Phase 1/Phase 2
Start date May 25, 2023
Completion date August 2025
View Details
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