慢性腎臓病に伴う貧血を有する日本人血液透析患者（赤血球生成刺激剤を服用していない患者）におけるGSK1278863の有効性および安全性に関する研究

基本情報

NCT ID

NCT02829320

ステータス

完了

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

28

治験依頼者名

GlaxoSmithKline

概要

This 24-week, Phase 3, open-label, non-comparative, multicentre study aims to evaluate the efficacy and safety of GSK1278863 in Japanese hemodialysis (HD) patients with renal anemia not using erythropoiesis-stimulating agents (ESAs). The primary objective is to evaluate the initial response to GSK1278863 measured by hemoglobin (Hgb) levels in HD patients not using ESAs enrolled in this study. The study is designed to evaluate the appropriateness of the starting dose of GSK1278863 and of the GSK1278863 dose adjustment regimen to achieve or maintain the target Hgb levels. This study will consist of a 4-week screening period, a 24-week treatment period (4-week fixed-dose period and a 20-week dose adjustment period), and a 2- to 4-week follow-up period.

対象疾患

介入

依頼者（Sponsor）

実施施設 (17)