EUCTR2016-000507-86-ES进行中（未招募）1 期
A 52-week open-label (sponsor-blind), randomized, active controlled,parallel-group, multi-center study to evaluate theefficacy and safety of daprodustat compared to recombinanthuman erythropoietin in subjects with anemia associated withchronic kidney disease who are initiating dialysis - ASCEND-ID
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 312
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •A subject will be eligible for inclusion in this study only if all of the following criteria apply at screening and randomization (Day 1) unless otherwise specified.
- •1. Age (confirm at screening): 18 to 99 years of age inclusive
- •2. Dialysis: Planning to start chronic dialysis within the next 4 weeks (from the date of the screening visit) OR have started and received dialysis (as specified below) for end-stage renal disease for a maximum of =90 days immediately prior to randomization and is not expected to stop dialysis during the duration of the trial:
- •- HD = 2X/week, or
- •- Daily PD (Including continuous and automated PD)
- •3. Hemoglobin concentration as measured by HemoCue (range inclusive): 8-10.5 g/dL (5-6.5 mmol/L) at screening and 8-11.0 g/dL (5-6.8 mmol/L) at randomization
- •4. Informed consent: capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in this protocol
- •Note: The country-specific requirements for France ONLY for the informed consent process is provided in Appendix 11 (see Section 12.11.1, Item 3 for details)
- •5. Other study eligibility criteria considerations: The country-specific requirements for France ONLY for the eligibility for inclusion in this study is provided in Appendix 11 (see Section 12.11.1, Item 1 for details)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 210
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
排除标准
- •A subject will not be eligible for participation in this study if any of the following criteria apply at screening or at randomization (Day 1), unless otherwise specified.
- •CKD-related criteria
- •1. Kidney transplant: Planned living-related donor kidney transplant during the study.
- •Anemia related criteria
- •2. Ferritin: =100 ng/mL (=100 µg/L) at screening or after IV iron supplementation.
- •3. TSAT: =20% at screening or after IV iron supplementation.
- •4. Vitamin B12: Below the lower limit of the reference range at screening or after vitamin B12 supplementation
- •5. Folate: <2.0 ng/mL (<4.5 nmol/ L) at screening
- •6. Aplasias: History of bone marrow aplasia or pure red cell aplasia (PRCA).
- •7. Other causes of anemia: Pernicious anemia, thalassemia major, sickle cell disease, or myelodysplastic syndrome.
- •8. Gastrointestinal (GI) bleeding: Evidence of actively bleeding gastric, duodenal, or esophageal ulcer disease OR clinically significant GI bleeding =10 weeks prior to screening through to randomization (Day 1).
- •Erythropoiesis treatment criteria
- •9. Use of any ESA treatment within 8 weeks prior to screening except for limited use as part of dialysis initiation. Limited use is defined as no more than 6 weeks of short acting ESA (rhEPO or biosimilars; maximum of 20000 U total) or long acting ESA (darbepoetin alfa [maximum of 100 µg total] or methoxy polyethylene glycol-epoetin beta [maximum of 125 µg total]) received before or after starting dialysis.
- •Cardiovascular disease-related criteria
- •10. Myocardial infarction or acute coronary syndrome: =10 weeks prior to screening through to randomization (Day 1).
- •11. Stroke or transient ischemic attack: =10 weeks prior to screening through to randomization (Day 1).
- •12. Heart failure: Chronic Class IV heart failure, as defined by the New York HeartAssociation (NYHA) functional classification system.
- •13. Current uncontrolled hypertension: Current uncontrolled hypertension as determined by the Investigator that would contraindicate the use of rhEPO.
- •14. QTcB (Day 1): QTcB >500 msec, or QTcB >530 msec in subjects with bundle branch block. There is no QTc exclusion for subjects with a predominantly paced rhythm
- •Other disease-related criteria
- •15. Liver disease (any one of the following):
- •- Alanine transaminase (ALT) >2x upper limit of normal (ULN) (screening only)
- •- Bilirubin >1.5xULN (screening only)
- •NOTE: Isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%.
- •- Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.
- •NOTE: Stable chronic liver disease (including asymptomatic gallstones, chronic hepatitis B or C, or Gilbert's syndrome) are acceptable if subjectotherwise meets entry criteria.
- •16. Malignancy: History of malignancy within the 2 years prior to screening through to randomization (Day 1), or currently receiving treatment for cancer, or complex kidney cyst (i.e. Bosniak Category II F, III or IV) > 3cm. The only exception is localized squamous cell or basal cell carcinoma of the skin that has been definitively treated =10 weeks prior to screening. Concomitant medications and other study treatment-related criteria
- •17. Severe allergic reactions: History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product (refer to daprodustat IB) or to da
研究者
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