Safety and Efficacy of a Phased Transition From Epogen to Three Times Weekly Oral Vadadustat for the Treatment of Anemia in Subjects Receiving In-Center Hemodialysis
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Proportion of patients starting three times per week vadadustat (TIW-V) who remain on TIW-V at week 20
研究概览
简要总结
The goal of this study is to assess if patients can be retained on long-term vadadustat therapy (and thus potentially benefit from the favorable safety profile) by incorporating a phased transition from Epogen to three times per week vadadustat (TIW-V), reducing the likelihood of GI intolerance through use of a lower vadadustat starting dose, and also reducing or eliminating the initial reduction in hemoglobin through the maintenance of low dose Epogen until target hemoglobin stability is achieved on a tolerable dose of TIW-V.
详细描述
This is a multi-center, single-arm, open-label study assessing the safety of a phased transition from Epogen to three times per week vadadustat (TIW-V) for the treatment of anemia in subjects receiving in-center hemodialysis.
Subjects who have signed an IRB-approved informed consent form and who meet all of the inclusion criteria and none of the exclusion criteria will simultaneously have their Epogen dose reduced by 50% and initiate 300 mg vadadustat TIW.
Subsequent dose modifications will occur in order to target a narrow hemoglobin range (10-11 g/dL). Patients will have their hemoglobin assessed every 2 weeks and will continue in the trial for up to 28 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients ≥18 years of age
- •Receiving outpatient in-center hemodialysis for ESKD at least TIW (prescribed)
- •Currently receiving EPO (active administration, not on HOLD)
- •Less than or equal to 0.75 g/d difference between last 2 Hgb values prior to Screening, with neither Hgb <9 g/dL
- •Average of last 2 Hgb between 9-11.4 g/dL (inclusive) prior to Screening
- •Central Screening Hgb 9-11.4 g/dL (inclusive)
- •Central Screening transferrin saturation greater than or equal to 20%
- •Central Screening serum ferritin greater than or equal to 100 ng/mL
- •Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure
排除标准
- •Contraindication to receive vadadustat per United States Prescribing Information (USPI) including Screening liver function tests greater than 3x the upper limit of normal (ULN)
- •Electronic Medical Record (EMR)-documented history of cirrhosis or active, acute liver disease
- •EMR-documented history of currently active malignancy excluding non-melanomatous skin cancer and in-situ cervical cancer
- •Concomitant use of HIF-PHI or OAT1/OAT3 inhibitors (probenecid, rifampicin, gemfibrozil, or teriflunomide)
- •Unable to comply with study requirements or in the opinion of a healthcare provider or member of the central study team, not clinically stable to participate in the study
- •Documented unplanned absence from dialysis greater than or equal to 3 times in 30 days prior to Screening (excluding rescheduled dialysis treatments)
- •Pregnant at time of consent (per subject self-report)
研究组 & 干预措施
Phased transition from Epogen to three times weekly (TIW) oral vadadustat
干预措施: Epoetin alga (Epogen)/vadadustat (Drug)
结局指标
主要结局
Proportion of patients starting three times per week vadadustat (TIW-V) who remain on TIW-V at week 20
时间窗: 20 weeks
次要结局
- Proportion of patients starting three times per week vadadustat (TIW-V) who do not demonstrate a drop in Hgb >0.75 g/dL at any point from baseline to week 20(20 weeks)
- Proportion of patients starting three times per week vadadustat (TIW-V) who achieve a mean Hgb in a range of 9-11.5 g/dL during weeks 20-24(weeks 20-24)
研究者
Geoff Block
Senior Vice President of Research and Associate Chief Medical Officer
USRC Kidney Research