Brief Summary
The purpose of this study is to evaluate the effects of KER-050 on anemia in patients with very low, low or intermediate riskthe possibility that something bad will happen MDS.
Intervention / Treatment
- Drug: KER-050
Inclusion Criteria
- Diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results of MDS according to World Health Organization (WHO)/French American British (FAB) classification that meets Revised International Prognostic Scoring System (IPSS-R) classification of very low, low, or intermediate risk disease.
- < 5% blasts in bone marrowsoft, spongy tissue found in bones that makes blood cells.
- Peripheral bloodthe red bodily fluid that transports oxygen and other nutrients around the body white blood cell count <13,000/µL.
- Anemia defined as:
- In non-transfused participants, having received no red blood cell (RBC) transfusions within 8 weeks Hgb concentration ≤ 10.0 g/dL OR
- In LTB participants, having received 1 to 3 units RBCs for Hgb ≤ 9.0 g/dL within 8 weeks OR
- In HTB participants, having received ≥ 4 units of RBCs for Hgb ≤ 9.0 g/dL within 8 weeks
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status of 0, 1, or 2 (if related to anemia.
- Females of child-bearing potential and sexually active males must agree to use effective methods of contraception.