GSK Chronic Kidney Disease 6581
A four-week Phase IIa, randomized, double-blind, placebocontrolled, parallel-group, multi-center study to evaluate the safety, efficacy and pharmacokinetics of GSK1278863 in subjects with anemia associated with chronic kidney disease who are not taking recombinant human erythropoietin and are not undergoing dialysis
| Protocol | |
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| Identifier | PHI116581 |
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| UID | 540d00ba-f932-4f5d-b359-19bae1e51eae |
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| Status | Done - Archived |
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| Phase | 2a |
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| Category | Chronic Kidney Disease / Adult |
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| Launch Year | 2012 |
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| NCT Number | - |
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| Created | 2012-04-24 13:58 |
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| Last Updated | 2012-04-24 13:58 |
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Description
Key Elements:
• Study purpose: To estimate the relationship between dose of GSK1278863 and hemoglobin response for correcting anemia in non-dialysis subjects with CKD who are not taking rhEPO.
• Study drug: In a new class of medications called PHIs being used to treat anemia associated with multiple causes. PHIs may be able to raise hemoglobin levels without increasing CV risk, which is seen in use of rhEPO.
• Study Drug Administration: 2 tablets daily
• 8 visits (8 weeks/2 months)
• Stipend: $31 for each visit (Except Week -2 and Week 4, which are $62)
Comment
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