Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
1 to of GSK1278863 · 1 trial · 1 indication
The mean hemoglobin during the primary efficacy evaluation period in ND participants was estimated by a statistical model using Mixed Model Repeated Measures (MMRM).
| Arm | Type | Description |
|---|---|---|
| Daprodustat in ND participants | EXPERIMENTAL | Eligible ND participants will receive oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 milligrams \[mg\] as recommended) dose once daily for 52 weeks. |
| Epoetin beta pegol in ND participants | ACTIVE_COMPARATOR | Eligible ND participants will receive subcutaneous (SC) epoetin beta pegol (25, 50, 75, 100, 150, 200 or 250 microgram \[µg\] as recommended) dose once every 2 or 4 weeks for 52 weeks. |
| Daprodustat in PD participants | EXPERIMENTAL | Eligible PD participants will receive oral daprodustat (1, 2, 4, 6, 8, 12, 18 or 24 mg as recommended) dose once daily for 52 weeks. |
| Name | Type | Description |
|---|---|---|
| 1 to 4 mg tablets of GSK1278863 | DRUG | 7.0 millimeters (mm) round, standard biconvex, white film coated tablets containing 1 mg, 2 mg, or 4 mg of GSK1278863 as active ingredient, to be orally administered once daily. |
| 6 mg GSK1278863 tablet | DRUG | 9.0 mm round, standard biconvex, white film coated tablets containing 6 mg of GSK1278863 as active ingredient, to be orally administered once daily. |
| Epoetin beta pegol | DRUG | An injectable formulation containing 25 micrograms µg, 50 µg, 75 µg, 100 µg, 150 µg, 200 µg, or 250 µg of epoetin beta pegol per syringe (0.3 mL), supplied as a glass syringe prefilled with epoetin beta pegol solution (clear colorless to pale yellow). Epoetin beta pegol will be subcutaneously administered once every 2 or 4 weeks. |
Inclusion Criteria: * Age (at the time of informed consent): \>=20 years of age * Screening verification only: Stage of chronic kidney disease (CKD) (ND subjects only): CKD stages 3, 4, and 5 defined by estimated glomerular filtration rate (eGFR) using the Japanese Society of Nephrology-Chronic Kid...
GSK1278863 is an investigational small molecule being developed for the treatment of anaemia, specifically renal anaemia. It is being studied in patients with chronic kidney disease who are not on dialysis or who are on peritoneal dialysis. The drug is currently in Phase 3 clinical development.
GSK1278863 is being developed by GSK plc, a global pharmaceutical company traded on the London Stock Exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with renal anaemia.
GSK1278863 is in Phase 3 clinical development. A Phase 3 study has been completed in Japanese patients with renal anaemia, including both non-dialysis and peritoneal dialysis patients. The drug is investigational and has not been approved by regulatory authorities.
GSK1278863 has one completed Phase 3 clinical trial, NCT02791763, which enrolled 355 participants in Japan. The study evaluated the drug in Japanese non-dialysis and peritoneal dialysis subjects with renal anaemia. The trial was active-controlled and randomized, and it has been completed.
GSK1278863 is also known as daprodustat, an investigational oral medication for anaemia associated with chronic kidney disease. The drug is being developed by GSK plc and is currently in Phase 3 clinical trials. It is not yet approved for use in any country.