Safety and efficacy study of FG-4592 in the Treatment of Anemia in Incident-dialysis Patients
- Conditions
- Diseases of the blood and blood -forming organs and certain disorders involving the immune mechanism
- Registration Number
- KCT0001691
- Lead Sponsor
- ovotech Asia Korea
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 750
1. Age = 18 years.
2. Receiving hemodialysis or peritoneal dialysis for end-stage renal disease for a minimum of 2 weeks and a maximum of 4 months, prior to study participation.
3. Study participant has permanent dialysis access in place.
4. No iron deficiency.
5. No folate or Vitamin B12 deficiency.
6. No abnormal liver tests.
7. Body weight up to 160 kg (HD(hemodialysis): dry weight).
Note: Blood tests will be conducted to determine whether or not study participant has anemia, and meets all eligibility criteria.
1. Any erythropoieisis-stimulating agent treatment within 12 weeks prior to participating in the study.
2. Intravenous iron within 10 days prior to participating in the study.
3. Red blood cell transfusion within 8 weeks prior to participating in the study.
4. Active infection.
5. Chronic liver disease (e.g., chronic infectious hepatitis, chronic auto-immune liver disease, cirrhosis, or fibrosis of the liver).
6. Congestive heart failure.
7. Heart attack, stroke, or blood-clots within a major vessel within 12 weeks prior to participating in the study.
8. Uncontrolled high blood pressure within 2 weeks prior to participating in the study.
9. Renal ultrasound performed within 12 weeks prior to participating in the study suspicious of renal cancer.
10. Active cancer.
11. Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
12. Chronic inflammatory disease that could cause anemia.
13. Known and untreated damage to the retina from diabetes.
14. Known history of blood-related diseases causing anemia, or blood-related cancer.
15. Known inherited disease such as thalassemia or sickle cell anemia or other known causes for anemia other than chronic kidney disease.
16. Known clotting disorders and iron storage disorders.
17. Any prior organ transplant (that has not been explanted), or a scheduled organ transplantation.
18. Anticipated surgery that is expected to cause blood loss.
19. Known gastrointestinal bleeding.
20. Any prior treatment with FG-4592 (roxadustat) or a hypoxia-inducible factor prolyl hydroxylase inhibitor.
21. Use of iron-binding medications within 4 weeks prior to participating in the study.
22. Known allergies to any erythropoieisis-stimulating agent.
23. Use of an investigational drug or treatment, participation in an investigational study, or presence of an expected carryover effect of an investigational treatment, within 4 weeks prior to participating in the study.
24. Anticipated use of dapsone or androgens at any dose amount or chronic use of acetaminophen or paracetamol >2.0 g/day during the study.
25. History of alcohol or drug abuse within 2 years prior to participating in the study.
26. Females of childbearing potential, unless using contraception as detailed in the protocol; male subjects with sexual partners of childbearing potential who are not on birth control unless the male subject agrees to use contraception.
27. Pregnant or breastfeeding women.
28. Any medical condition, that in the opinion of the study doctor, may pose a safety risk to the patient, may confound efficacy or safety assessment, or may interfere with study participation
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of subjects who achieve a Hb response during the first 24 weeks of treatment
- Secondary Outcome Measures
Name Time Method Mean Hb(Hemoglobin) change from baseline to average level from Week 28 to Week 52;Average monthly IV(intravenous) iron use per subject during the Treatment Period;Mean change in low-density lipoprotein(LDL) cholesterol;Proportion of subjects with exacerbation of hypertension;Time to achieve first Hb(Hemoglobin) response as defined by the primary endpoint;Health-related quality of life: SF-36(The 36-Item Short Form Health Survey) FACT-AN(Functional Assessment of Cancer Therapy-Anemia), EQ-5D-5L(European Quality of Life in 5 Dimensions, 5 Levels);Additional efficacy analysis: Hemoglobin maintenance, rescue therapy, hospitalizations, other additional labs of interest.