A Study of GSK1278863 in the treatment of aneamia in Dialysis patients

• Research type

  Research Study

• Full title

  A Phase 2B, randomized, blinded, dose-ranging, active-controlled, parallel-group, multi-center study to evaluate the dose response relationship of GSK1278863 over the first 4 weeks of treatment and evaluate the safety and efficacy of GSK1278863 over 24 weeks in hemodialysis-dependent subjects with anemia associated with chronic kidney disease who switch from recombinant human erythropoietin.

• IRAS ID

  138390

• Contact name

  Sandip Mitra

• Contact email

  sandip.mitra@cmft.nhs.uk

• Sponsor organisation

  GlaxoSmithKline

• Eudract number

  2013-002682-19

• Research summary

  The purpose of this study is to find the best dose and test the safety and efficacy (how well a medicine works) of GSK1278863 in treating anaemia of chronic kidney disease (CKD). Anaemia is a condition where the amount of haemoglobin (protein in blood that carries oxygen) is below normal level or there are fewer red blood cells than normal. Eligible subjects are on dialysis and taking Erythropoietin (EPO) for anaemia of CKD.
  Subjects stay in the study for 32 weeks with a 4 week screening (monitoring) part, 24 weeks treatment part and then a follow up visit 4 weeks after finishing treatment. Suitable subjects will stop taking EPO injections and will receive either GSK1278863 or placebo (dummy with no drug) once daily. Treatments will be allocated randomly with neither the patient nor their doctor able to choose which treatment is given. Out of every 11 people, 9 will get GSK1278863 at different doses and 2 will get placebo. After 4 weeks treatment, subjects receiving placebo will return to EPO treatment for the rest of the study. Doses may be adjusted until study end for all subjects.
  Subjects will attend fortnightly for blood tests and will see a doctor every 4 weeks. The study visits should be at the same time as the regular dialysis sessions. The only exceptions to this are 3 eye exams/echocardiograms as these will be done at a separate clinic in the hospital.
  Tests/procedures include
  • Physical examination & medical history, heart monitoring
  • Various blood tests (including pregnancy tests for women who can become pregnant)
  • Pharmacokinetic blood tests (to measure the amount of study drug in the blood)
  • Vital signs: weight, height, blood pressure and pulse
  • eye exams and echocardiograms- scans which test how your heart pumps blood
  • Subject questionnaires

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  13/NW/0791

• Date of REC Opinion

  27 Nov 2013

• REC opinion

  Favourable Opinion