PK Study of GSK1278863
Research type
Research Study
Full title
A repeat-dose, open-label, parallel-group study to assess the pharmacokinetics of GSK1278863 and metabolites in subjects with End Stage Renal Disease undergoing peritoneal dialysis.
IRAS ID
163904
Contact name
Tim Mant
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Ltd
Eudract number
2014-001197-34
Research summary
GlaxoSmithKline group of companies is developing a new drug (GSK1278863) for potential treatment of low red blood cell count or anaemia associated with chronic kidney disease (CKD). Red blood cells are responsible for transporting oxygen around the body. Subjects with anaemia may experience tiredness, shortness of breath, heart problems, and difficulty with memory.
The current treatment for anaemia is; iron supplementation, blood transfusions and/or injections with drugs that act in the same way as erythropoietin (Epo). Epo is a hormone made mostly in the kidneys and somewhat in the liver that stimulates red blood cell production. Subjects with CKD do not make enough Epo, and often have anaemia.
GSK1278863 works by blocking certain enzymes in the body. Blocking these enzymes causes the body to make more Epo and red blood cells. GSK1278863 is a study drug which, unlike Epo,is taken as tablets by mouth and may provide a new treatment option for subjects with anaemia of CKD.The purpose of this study is to understand how the body processes (absorbs into the blood stream, breaks down and eliminates) the study drug in subjects with CKD on peritoneal dialysis. We will also look at how people on peritoneal dialysis react to GSK1278863.
Approximately 30 patients in 2 countries will be recruited in the study, to achieve atleast 12 completed data sets. Grouped into 2,one group of 6 patients will be on continuous ambulatory peritoneal dialysis (CAPD), and the second group of 6 patients will be on automated peritoneal dialysis (APD).
The total participation time in the study is 8 weeks, in which the patients will have 14 days treatment as in patient in the unit or as outpatient according to their preference. Procedures to be carried out during the study include blood pressure check, ECG, urine and blood tests and physical examination.REC name
HSC REC A
REC reference
14/NI/1098
Date of REC Opinion
5 Nov 2014
REC opinion
Further Information Favourable Opinion