Safety and efficacy study of Roxadustat(FG-4592) for the Treatment of Anemia in Chronic Kidney Disease Patients not on Dialysis

Not Applicable

Recruiting

Conditions: Diseases of the blood and blood -forming organs and certain disorders involving the immune mechanism

Registration Number: KCT0001690

Lead Sponsor: ovotech Asia Korea

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 600

Inclusion Criteria

1. Chronic kidney disease, Stage 3, 4, or 5, not receiving dialysis
2. Anemia qualified by measurements of hemoglobin values during screening
3. Additional blood work must be in a safe range for study entry
4. Body weight 45 to 160 kg
5. Willingness to use contraception if of child-bearing potent

Exclusion Criteria

1. Treatment with an erythropoiesis-stimulating agent (ESA) within 12 weeks prior to study participation
2. More than one dose of intravenous iron within 12 weeks prior to study participation
3. Blood transfusion within 8 weeks prior to study participation
4. Active infection
5. Chronic liver disease
6. Severe congestive heart failure, recent heart attack, stroke, seizure, or blood clot
7. Uncontrolled blood pressure within 2 weeks prior to study participation
8. Renal cell carcinoma
9. History of malignancy, including multiple myeloma or other myelodysplastic syndrome
10. Chronic inflammatory disease that could impact red blood cell production
11. Any prior organ transplant, or a scheduled organ transplantation
12. Anticipated elective surgery that is expected to lead to significant blood loss, or anticipated elective heart procedure
13. Gastrointestinal bleeding
14. Any prior treatment with FG-4592(roxadustat) or a HIF-PHI(hypoxia-inducible factor prolyl hydroxylase inhibitor)
15. Recent use of an investigational drug or treatment, or participation in an investigational study

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of roxadustat(FG-4592) for the treatment of anemia correction and maintenance;Efficacy of roxadustat(FG-4592) in achieving hemoglobin correction and maintenance (as defined in protocol) in CKD(chronic kidney disease) subjects not on dialysis

Secondary Outcome Measures

Name	Time	Method
Change in low-density lipoprotein (LDL) cholesterol;Evaluate health-related quality of life benefits, as measured by the 36-Item Short Form Health Survey (SF-36);Proportion of patients who received rescue therapy (composite of RBC(red blood cell) transfusion, ESA use, and IV(intravenous) iron);Change in mean arterial pressure and effect on reducing hypertension;Adverse events, serious adverse events, vital signs, electrocardiograms and physical exams