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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 2 | PHASE3 | Luspatercept |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 2 | PHASE3 | Elritercept |
| Disc Medicine, Inc. | IRON | 2 | PHASE2 | DISC-0974 |
| Akebia Therapeutics, Inc. | AKBA | 2 | PHASE3 | Vadadustat |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | APG-5918 |
| Bayer | BAYRY | 1 | - | Molidustat |
GSK1278863 is being developed for the treatment of anaemia, specifically renal anaemia in patients with chronic kidney disease. It is an investigational small molecule that has been studied in Japanese non-dialysis and peritoneal dialysis subjects. It is not yet approved for any indication.
GSK1278863 is being developed by GSK plc, which trades under the ticker GSK. The company sponsored the Phase 3 clinical trial evaluating the drug in patients with renal anaemia.
GSK1278863 is in Phase 3 clinical development. One Phase 3 trial has been completed, and no active trials are currently listed. The drug remains investigational and has not been approved by the FDA or other regulators.
GSK1278863 has been evaluated in a single Phase 3 trial, NCT02791763, titled a Phase III Study of GSK1278863 in Japanese Non-dialysis and Peritoneal Dialysis Subjects With Renal Anemia. The trial enrolled 355 participants in Japan and has been completed.