Conditions: Anemia
Keywords: recombinant human erythropoietin GSK1278863 hemodialysis anemia Hemoglobin chronic rhEPO hyporesponsiveness chronic kidney disease erythropoiesis stimulating agents pharmacokinetics
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 15
Healthy volunteers: no

Brief summary:
The study will evaluate the ability of GSK1278863 to increase the hemoglobin (Hgb) concentration, or maintain it within the target range, and the safety and efficacy of GSK1278863 over 16 weeks of treatment, in hemodialysis-dependent subjects with anemia associated with chronic kidney disease who are chronically hyporesponsive to rhEPO. The data generated will inform dose requirements for any chronic rhEPO hyporesponsive hemodialysis-dependent subjects included in future clinical trials. The study consists of a 4-week rhEPO run-in period, a 16-week GSK1278863 treatment period and a 4-week Follow-up period.

Detailed description:

Arms:
arm 1: Subjects will receive a fixed starting dose of 12 milligrams (mg) GSK1278863 once daily (QD) orally for first 4 weeks. From Week 4 the dose of GSK1278863 will be adjusted based on Hgb levels and evaluated every 4 weeks until Week 16. This starting dose may be changed during the study if there is an early indication of either lack of efficacy or the rate of rise in Hgb is too rapid

Interventions: intervention 1: GSK1278863 intervention 2: Placebo
Intervention descriptions: intervention 1: Film coated tablets containing 1 mg, 2 mg, 5 mg or 25 mg of GSK1278863 intervention 2: Matching placebo tablet for GSK1278863

Protocol document: