NCT01906489已完成2 期
Phase 2b Randomized, Double-Blind, Placebo-Controlled Study to Assess the Pharmacodynamic Response, Safety, and Tolerability to 20 Weeks of Oral Dosing of AKB-6548 in Participants With Anemia Secondary to Chronic Kidney Disease (CKD), GFR Categories G3a-G5 (Stages 3, 4, AND 5) (Pre-Dialysis)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 210
- 主要终点
- Percentage of Participants Achieving a Successful Hemoglobin Response
研究概览
简要总结
The purpose of this study is to evaluate the hemoglobin response (efficacy), safety, and tolerability of orally administered AKB-6548 in participants with Chronic Kidney Disease (pre-dialysis) with anemia with dosing for 20 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 82 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 82 years of age, inclusive
- •Chronic Kidney Disease with a GFR category of G3a-G5 and not yet on dialysis
- •eGFR ≥ 10 and ≤ 65 mL/minute/1.73 m2
- •Anemia secondary to CKD with an ESA status and a Screening HGB as per protocol
- •Iron replete with ferritin and TSAT levels as defined per protocol
排除标准
- •BMI > 44.0 kg/m2
- •Red blood cell transfusion within 11 weeks prior to the Screening visit
- •Androgen therapy within the previous 21 days prior to the Screening visit
- •Intravenous iron within the past 4 weeks prior to the Screening visit
- •AST or ALT >1.8x ULN, alkaline phosphatase >2x ULN, or total bilirubin >1.5x ULN
- •Screening ECG with QTc > 500 msec
- •Uncontrolled hypertension
- •Class III or IV congestive heart failure
- •Myocardial infarction, acute coronary syndrome, or stroke within 6 months prior to the Screening visit
研究组 & 干预措施
AKB-6548
Experimental
干预措施: AKB-6548 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Achieving a Successful Hemoglobin Response
时间窗: Weeks 19 and 20
Hemoglobin (Hgb) response was defined as participants with mean Hgb ≥11.0 grams per deciliter (g/dL) (average of Weeks 19 and 20) or increase in Hgb by ≥ 1.2 g/dL (average of Weeks 19 and 20) over pre-dose average (average of the two Hgb values obtained prior to dosing) without receiving Erythropoiesis-Stimulating Agents (ESA) or transfusion.
次要结局
- Percentage of Participants Achieving a Successful Hemoglobin Response, Determined Solely Based on the Hemoglobin Value(Weeks 19 and 20)
- Percentage of Participants Achieving a Successful Hemoglobin Response in ESA Treatment naïve Group(Weeks 19 and 20)
- Percentage of Participants Achieving a Successful Hemoglobin Response in ESA Previously Treated Group(Weeks 19 and 20)
- Absolute Values of Hematocrit(Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20)
- Percentage of Participants With Hemoglobin Value ≥13.0 g/dL at Any Time During the Study(Up to 20 Weeks)
- Percentage of Participants Achieving a Successful Hemoglobin Response in ESA Actively Treated Group(Weeks 19 and 20)
- Percentage of Participants Achieving a Successful Hemoglobin Response, Analyzed in mITT Population(Weeks 19 and 20)
- Absolute Values of Hemoglobin(Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20)
- Time to First Transfusion or ESA Rescue Medication Intake(Up to 20 Weeks)
- Change From Baseline in Red Blood Cell Count(Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20)
- Number of Packed Red Blood Cell Transfusion Administered Per Participant(Up to 20 Weeks)
- Number of Participants With Clinically Abnormal 12-Lead Electrocardiogram (ECG) Findings(Up to 20 Weeks)
- Change From Baseline in Hematocrit(Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20)
- Absolute Values of Red Blood Cell Count(Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20)
- Absolute Values of Reticulocyte Count(Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20)
- Percentage of Participants Who Received ESA Rescue(Up to 20 Weeks)
- Mean Number of ESA Rescue Doses Administered Per Participant(Up to 20 Weeks)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (SAEs)(Up to 20 Weeks)
- Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values(Up to 20 Weeks)
- Change From Baseline in Hemoglobin(Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20)
- Change From Baseline in Reticulocyte Count(Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 19 and Week 20)
- Percentage of Participants Who Received Packed Red Blood Cell Transfusion Rescue(Up to 20 Weeks)
- Number of Participants With Clinically Significant Changes From Baseline in Vital Signs(Up to 20 Weeks)
- Number of Participants With Clinically Significant Changes From Baseline in Physical Examination Findings(Up to 20 Weeks)
研究者
相似试验
已完成
2 期
16-Week Repeat Oral Dose Study of AKB-6548 for Anemia in Participants With End Stage Renal Disease (ESRD) Requiring Chronic HemodialysisEnd Stage Renal DiseaseAnemiaNCT02260193Akebia Therapeutics94
已完成
3 期
A Study of Subjects With Previously Untreated Extensive-Stage Small-Cell Lung Cancer (SCLC) Treated With Platinum Plus Etoposide Chemotherapy With or Without Darbepoetin AlfaSmall Cell Lung CancerNCT00119613Amgen600
已完成
2 期
Heart Failure and AnemiaHeart FailureAnemiaNCT00049985Amgen300
终止
不适用
A Randomized Clinical Trial on Hemoglobin Dose and Patient MatchingAnemiaNCT01328262Haukeland University Hospital12
已完成
1 期
Safety and Immunogenicity of PanBlok Influenza Vaccine in Healthy AdultsInfluenzaNCT01612000Protein Sciences Corporation341