FG-4592-082 (Roxadustat) Clinical Trial Open to Recruitment16 Sep. 2019
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- SUB-TYPE OF MDS:Lower Risk MDS With Low Red Blood Cell Transfusion Burden
- SEVERITY OF MDS: IPSS-R classification very low, low or intermediate risk with <5% blasts
- NAME OF DRUG: Roxadustat
- Aims and benefits: To determine whether Roxadustat is safe and effective in treating anaemia in patients with Primary Lower Risk Myelodysplastic Syndrome and Low Red Blood Cell Transfusion Burden.
Roxadustat is an oral preparation that stimulates erythropoiesis (production of red cells) by increasing the body’s production of the hormone erythropoietin and it regulates the way in which the body uses iron. This study is a Phase 3 Randomized Double-Blind Placebo-Controlled Study in which there is a treatment period of 52 weeks and a 4 week end of treatment assessment.
- Primary outcome measures:
To determine how effective Roxadustat is at correcting and maintaining the haemoglobin and reducing the number of red cell transfusions needed.
- Secondary outcome measures:
To establish the effect of Roxadustat on clinical observations (including blood pressure, heart rate and ECG), how it affects red blood cell transfusion requirements and its effect on quality of life.
- Basic inclusion criteria:
- Primary MDS classified as very low, low or intermediate risk with <5% blasts
- Low red blood cell transfusion requirement (either 2-4 units over the 8 weeks prior to randomization or 1 unit in two consecutive periods of 8 weeks within the 16 weeks prior to randomization)
- ECOG performance of 0 – 2 at screening
- Basic exclusion criteria:
- Diagnosis of secondary MDS
- Significant myelofibrosis
- MDS associated with 5q(del) abnormality
- Serum erythropoietin level > 400 mIU/mL
- Clinically significant anaemia due to other causes (unrelated to MDS)
- Trial sites/locations and name of physician in charge of trial:
- King’s College Hospital, London
- Pilgrim Hospital Boston, Lincolnshire
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