NCT04215120已完成3 期
A Phase 3, Multicenter, Open-label, Randomized, Active-controlled Study to Evaluate the Efficacy and Safety of Desidustat Tablet Versus Epoetin Alfa Injection for the Treatment of Anemia in Patients With Chronic Kidney Disease (CKD) on Dialysis (DREAM-D)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 392
- 试验地点
- 7
- 主要终点
- Hemoglobin level
研究概览
简要总结
A phase 3, multicenter, open-label, randomized, active-controlled study to evaluate the efficacy and safety of Desidustat Tablet versus Epoetin alfa Injection for the treatment of anemia in patients with CKD on dialysis. (DREAM-D)
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to understand and give informed consent for participation.
- •Hemoglobin values during the screening period must be 8-11 g/dL (both inclusive).
- •Patients will be considered not treated with erythropoietin analogue (Epoetin and Darbepoeitin) if they have not received erythropoietin analogue for at least 4 weeks and Mircera® for at least 8 weeks prior to screening visit. OR
- •Patients who are on ESA therapy must be on stable dose for 4 weeks prior to enrollment (≤30% of dose change).
- •Patients on hemodialysis (≥2 times in a week) for at least 12 weeks prior to screening visit and have access consisting of an arteriovenous fistula, AV graft, or catheter (permanent/temporary).
- •Patients with no planned change in dialysis modality and with no planned renal transplant during study period.
- •Left ventricular ejection fraction ≥40% by echocardiogram prior to randomization.
- •No iron, folate or Vitamin B12 deficiency.
- •Females of childbearing potential, must agree to use one of the approved contraception methods, from screening until completion of the follow-up visit.
排除标准
- •Red blood cell transfusion within 8 weeks prior to participating in the study.
- •History of previous or concurrent cancer.
- •Serologic status reflecting active hepatitis B or C infection or Human immunodeficiency virus (HIV) infection.
- •Active infection at initiation of study.
- •History of renal transplant.
- •Uncontrolled hypertension (defined as SBP >180 mmHg or DBP >100 mmHg) at screening visit (before dialysis).
- •Patient on high rhEPO dose at screening visit. [High dose defined as an epoetin dose of ≥450 IU/kg/week intravenous or ≥ 300 IU/kg/week subcutaneous or darbepoetin dose of ≥1.5 µg/kg/week subcutaneous].
- •Major surgery within 90 days of the first day of study drug dosing, and minor surgery within 30 days of the first day of study drug dosing.
- •Unable to swallow tablets or disease significantly affecting gastrointestinal function and/or inhibiting small intestine absorption such as; malabsorption syndrome, resection of the small bowel or poorly controlled inflammatory bowel disease affecting the small intestine.
- •History of uncontrolled autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura (ITP) or thalassemia.
- •Presence or a history of bleeding disorders or clinical conditions (e.g. gastrointestinal [GI] bleeding or constitutional disorders) that may increase risk of life-threatening bleeding.
- •History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to Desidustat or Epoetin alfa or to any erythropoieisis-stimulating agent.
- •Pregnant and breastfeeding women.
- •Current life-threatening illness, medical condition or organ system dysfunction which, in the Investigator's opinion, could compromise the patient's safety.
- •Other laboratory abnormalities that, in the opinion of the investigator, would compromise the patient's safety or interfere with data interpretation.
- •Presence of other clinically significant systemic disorders or diseases (e.g., respiratory, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease or any other body system involvement) which, in the Investigator's opinion, could compromise the patient's safety.
- •History of significant alcoholism or drug abuse within the past 1 year. History or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco/nicotine products (more than 10 times per day).
- •History of difficulty with donating blood.
- •History or presence of any clinically significant electrocardiogram (ECG) abnormalities during screening.
- •Participants who have participated in any drug research study other than the present trial within past 3 months.
- •Participants who have donated one unit (350 ml) of blood in the past 3 months or history of whole blood transfusion in last 120 days prior to entry in the study.
- •Existing clinically active chronic inflammatory disease (RA, Celiac disease, UC, Crohns disease)
- •In case of DM patients, HbA1c >9%.
- •Female volunteers with following criteria will not be recruited:
- •History of pregnancy or lactation in the past 3 months
- •Fertile female volunteers not protected against pregnancy by adequate long- term anti-fertility measures
- •History of less than 1 year of menopause and not using adequate long-term anti-fertility measures
- •Positive urine pregnancy test at Visit 2
- •Positive serum β-hCG level at the screening visit
- •Currently active clinically significant cardiovascular disease such as uncontrolled arrhythmia, congestive heart failure, any class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification or history of myocardial infarction prior to first dose with study drug.
研究组 & 干预措施
Desidustat oral tablet
Active Comparator
Randomly assigned to receive Desidustat 100 mg in a 1:1 ratio for 24 weeks.
干预措施: Desidustat Oral Tablet (Drug)
Epoetin Injection
Experimental
Randomly assigned to receive Epoetin in a 1:1 ratio for 24 weeks.
干预措施: Epoetin Alfa (Drug)
结局指标
主要结局
Hemoglobin level
时间窗: 24 weeks
Change in Hb levels from baseline
次要结局
- Hemoglobin Response(24 weeks)
- Hemoglobin target range(24 weeks)
研究者
研究点 (7)
Loading locations...
相似试验
已完成
3 期
Efficacy and Safety of Actilyse 2 mg/ 2 ml in Comparison to Saline Solution in Patients With Central Venous Access Device OcclusionCatheter ObstructionVascular Access DevicesNCT01958164Boehringer Ingelheim16
进行中（未招募）
3 期
Ropeginterferon Alfa-2b (P1101) vs. Anagrelide in Essential Thrombocythemia Patients With Hydroxyurea Resistance or IntoleranceEssential ThrombocythemiaNCT04285086PharmaEssentia174
已完成
3 期
A Study to Compare the Effectiveness and Safety of IBI310 Combined With Sintilimab Versus Sorafenib in the First-line Treatment of Advanced HCCHepatocellular CarcinomaNCT04720716Innovent Biologics (Suzhou) Co. Ltd.344
已完成
3 期
A Study of Atezolizumab Compared With Docetaxel in Non-Small Cell Lung Cancer (NSCLC) After Failure With Platinum-Containing ChemotherapyCarcinoma, Non-Small-Cell LungNCT02813785Hoffmann-La Roche565
终止
3 期
A Phase 3 Clinical Study to Evaluate Lemzoparlimab for Injection in Combination With Azacitidine (AZA) Versus AZA Monotherapy in Treatment-naïve Patients With Higher-risk Myelodysplastic Syndrome (MDS)Myelodysplastic Syndromes(MDS)NCT05709093TJ Biopharma Co., Ltd.10