NCT02652806已完成3 期
A Phase 3, Randomized, Open-Label, Active-Controlled Study of Efficacy and Safety of FG-4592 for Treatment of Anemia in Subjects With Chronic Kidney Disease on Dialysis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- FibroGen
- 入组人数
- 305
- 试验地点
- 31
- 主要终点
- Hb mean change from baseline
研究概览
简要总结
This is a randomized, multicenter, open-label, active-controlled study of the treatment of anemia in subjects with CKD on dialysis, with treatment up to 52 weeks.
详细描述
This is a randomized, multicenter, open-label, active-controlled study of the treatment of anemia in subjects with CKD on dialysis. Eligible subjects are randomized to FG-4592 or epoetin alfa at a ratio of 2:1. The primary endpoint is Hb mean change from baseline averaged over Weeks 23 to 27.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18 to 75 years
- •Subject has voluntarily signed and dated an informed consent form (ICF), approved by an Ethics Committee (EC), after the nature of the study has been explained and the subject has had the opportunity to ask questions; a separate ICF is needed for subjects participating in the PK Sub-study.
- •"Chronic kidney disease with end-stage renal disease (ESRD) on either adequate hemodialysis (HD) or adequate peritoneal dialysis for a minimum of 16 weeks prior to Day 1: For subjects undergoing HD, the vascular access must be via native arteriovenous (AV) fistula or graft, or permanent, tunneled catheter."
- •Subjects must be on stable doses of IV or subcutaneous (SC) injections of epoetin alfa for at least 6 weeks prior to Day 1 (average dose ≤15,000 IU/week)
- •Mean of the two most recent central laboratory Hb values during the Screening Period, obtained at least 6 days apart, must be 9.0 g/dL to 12.0 g/dL, inclusive, with a difference of \≤1.5 g/dL between the highest and the lowest Hb values.
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5 x upper limit of normal (ULN), and normal total bilirubin at screening visit except for subjects with Gilberts syndrome (based on central laboratory results).
- •Body weight: 45 to 100 kg inclusive 8 Subjects agree not to start taking any new Traditional Chinese Medicine (TCM) for anemia and not to change dose, schedule, or brand of any prescreening TCM for anemia from beginning of Screening Period through end of Follow-up Period.
排除标准
- •Any clinically significant infection or evidence of an active underlying infection.
- •Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus antibody (anti-HCV Ab).
- •Chronic liver disease.
- •New York Heart Association Class III or IV congestive heart failure.
- •Myocardial infarction, acute coronary syndrome, stroke, seizure, or a thromboembolic event (eg, deep venous thrombosis or pulmonary embolism) within 52 weeks prior to Day
- •Uncontrolled hypertension in the opinion of the investigator (eg, that requires change in anti-hypertensive medication within 2 weeks prior to randomization).
- •Diagnosis or suspicion (eg, complex kidney cyst of Bosniak Category II or higher) of renal cell carcinoma as shown on screening renal ultrasound.
- •History of malignancy except the following: cancers determined to be cured or in remission for ≥5 years, curatively resected basal cell or squamous cell skin cancers, or in situ cancer at any site.
- •Chronic inflammatory disease other than glomerulonephritis that could impact erythropoiesis (eg, systemic lupus erythematosis [SLE], rheumatoid arthritis, celiac disease).
- •Clinically significant gastrointestinal bleeding.
- •Known history of myelodysplastic syndrome, multiple myeloma, hereditary hematologic disease such as thalassemia, sickle cell anemia, pure red cell aplasia, or other known causes for anemia other than CKD, hemosiderosis, hemochromatosis, known coagulation disorder, or hypercoagulable condition.
- •Any prior functioning organ transplant or a scheduled organ transplantation, or anephric.
- •Anticipated elective surgery that could lead to significant blood loss during the study period.
- •Anticipated use of dapsone or acetaminophen (paracetamol) >2.0 g/day, or >500 mg per dose repeated every 6 hours for more than 3 days.
- •Serum albumin <2.5 g/dL.
- •Androgen, deferoxamine, deferiprone, or deferasirox therapy within 12 weeks prior to Day
- •Life expectancy of <12 months.
- •Blood transfusion within 12 weeks prior to Day 1 or anticipated need for transfusion.
- •IV iron supplement during the Screening Period and /or unwilling to withhold IV iron.
- •Immune suppressive or systematic steroid treatment within 12 weeks prior to Day
- •History of alcohol or drug abuse within the past 2 years and inability to avoid consumption of more than >3 alcoholic beverages per day.
- •Prior treatment with FG-4592 or any hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI).
- •Use of an investigational medication or treatment, participation in an investigational interventional study, or carryover effect of an investigational treatment expected during the study.
- •Women who are pregnant or breastfeeding.
- •Women of childbearing potential and men with sexual partners of child bearing potential who are not using adequate contraception.
- •Any medical condition that, in the opinion of the investigator, may pose a safety risk to a subject in this study, may confound efficacy or safety assessment, or may interfere with study participation.
研究组 & 干预措施
FG-4592
Experimental
Intervention is investigational treatment FG-4592
干预措施: FG-4592 (Drug)
EPO
Active Comparator
Intervention is subject's current dose of Li Xue Bao (epoetin alfa)
干预措施: Epoetin Alfa (Drug)
结局指标
主要结局
Hb mean change from baseline
时间窗: Weeks 23 to 27.
Hb mean change from baseline
次要结局
- Mean change from baseline in low-density lipoprotein (LDL) cholesterol(Weeks 25-27)
- Number of subjects with a Hb response(Weeks 23-27)
- Percent of subjects with a Hb response(Weeks 23-27)
- Effect on iron metabolism(Week 27)
- Proportion of subjects with exacerbation of hypertension(Up to Week 27)
- Mean change from baseline in predialysis and postdialysis mean arterial blood pressure(Weeks 23-27)
- Number of subjects with treatment-emergent adverse events (TEAEs).(Week 1 to up to Week 53)
- Percent of subjects with treatment-emergent adverse events (TEAEs).(Week 1 to up to Week 53)
- Changes from baseline in vital signs(Week 1 to up to Week 53)
- Changes from baseline in ECG findings.(Week 1 to up to Week 53)
- Changes from baseline in clinical laboratory values.(Week 1 to up to Week 53)
- Number and % of subjects on rescue therapy during study treatment.(Week 1 to up to Week 53)
- Time to rescue therapy from date of first dose during study treatment.(Week 1 to up to Week 53)
研究者
研究点 (31)
Loading locations...
相似试验
已完成
3 期
Study to Evaluate Vadadustat for the Correction of Anemia in Participants With Non-dialysis-dependent Chronic Kidney DiseaseNon-Dialysis-Dependent Chronic Kidney DiseaseAnemiaNCT02648347Akebia Therapeutics1,751
已完成
3 期
Roxadustat in the Treatment of Anemia in End Stage Renal Disease (ESRD) Patients on Stable DialysisEnd Stage Renal Disease (ESRD)AnemiaNCT02278341Astellas Pharma Europe B.V.838
已完成
3 期
A Phase 3 Study to Investigate the Safety and Efficacy of PA21, a Phosphate Binder, in Dialysis PatientsChronic Kidney Disease Requiring Chronic DialysisNCT01324128Vifor Pharma1,059
终止
3 期
Efficacy and Safety Evaluation of EN3348 (Mycobacterial Cell Wall-DNA Complex [MCC]) as Compared With Mitomycin C in the Intravesical Treatment of Subjects With BCG Recurrent/Refractory Non-muscle Invasive Bladder CancerBladder NeoplasmNeoplasm Recurrence, LocalTransitional Cell, CarcinomaCarcinoma in SituMycobacteriumNCT01200992Bioniche Life Sciences Inc.84
已完成
3 期
Study to Evaluate the Efficacy and Safety of Toripalimab in Combination With Axitinib Versus Sunitinib Monotherapy in Advanced Renal Cell CancerPrimary Disease: Unresectable or Metastatic Renal Cell Carcinoma Focus of the Study:PFS Assessed by IRC Per RECIST 1.1NCT04394975Shanghai Junshi Bioscience Co., Ltd.421