CTRI/2018/04/013108进行中（未招募）3 期
A 52-week open-label (sponsor-blind), randomized, active-controlled, parallel-group, multi-center study to evaluate the efficacy and safety of daprodustat compared to recombinant human erythropoietin in subjects with anemia associated with chronic kidney disease who are initiating dialysis. - ASCEND-ID
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. 18 to 99 years of age inclusive.
- •2. Planning to start chronic dialysis within the next 6 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 less than or equal to 90 days immediately prior to randomization and is not expected to stop dialysis during the duration of the trial: HD is greater than or equal to 2 times per week or PD greater than or equal to 4 times per week including incremental schedule; subjects on continuous ambulatory peritoneal dialysis (CAPD) and automated peritoneal dialysis (APD) are eligible.
- •3. Hemoglobin concentration as measured by HemoCue (range inclusive): 8 to 10.5 g/dL (5-6.5 millimoles per liter [mmol/L]) at screening and 8-11.0 g/dL (5 to 6.8 mmol/L) at randomization.
- •4. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.
排除标准
- •-Use of ESA treatment within 8 weeks prior to screening except for limited use as part of dialysis initiation.
- •-Limited use allowed of no more than 6 weeks before or after starting dialysis of the following: of short-acting ESA (rhEPO or biosimilars; max. 20000 U total)
- •or long-acting ESA -darbepoetin alfa (max. 100 µg total) or methoxy polyethylene glycol-epoetin beta (max. 125 µg total)
- •2. CKD related:
- •- Planned living-related (and unrelated) kidney transplant during the study
- •3. Anemia related:
- •- Ferritin (screening or after IV iron supplementation): =100 ng/mL (=100 mcg/L)
- •- Transferrin saturation (TSAT) (screening or after IV iron supplementation): =20%
- •- Folate (screening only): <2.0 ng/mL ( <4.5 nmol/L)
- •- Vitamin B12 (screening or after vitamin B12): below the lower limit of reference range
- •- Aplasias: History of bone marrow aplasia or pure red cell aplasia (PRCA)
- •- Other causes: Pernicious anemia, thalassemia major, sickle cell disease or myelodysplastic syndrome
- •- Gastrointestinal (GI) bleeding (evidence of ulcers OR clinically significant GI bleeding =10 weeks prior to study)
- •4. Cardiovascular disease related:
- •- MI or ACS, Stroke or TIA =10 weeks prior to study; chronic Class IV heart failure (defined by NYHA); Current uncontrolled hypertension (preclude ESA use)
- •- 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 ventricular paced rhythm.
- •5. Other disease related:
- •-Liver: ALT >2x upper limit of normal (ULN) & bilirubin >1.5xULN; Current unstable or severe active liver or biliary disease
- •- History of malignancy within the two years prior to screening or currently receiving treatment for cancer, or known complex kidney cyst (i.e. Bosniak Category II F, III or IV) > 3cm.
- •6. Concomitant medication and other study treatment related criteria:
- •- Severe allergic reactions to daprodustat or rhEPO comparator.
- •- Strong inhibitor of CYP2C8 (e.g., gemfibrozil) or strong inducers of CYP2C8 (e.g., rifampin /rifampicin).
- •- Participation in other investigational agent/device study
- •- Any prior treatment with daprodustat for > 30 days.
- •- Pregnancy or lactation; other conditions
研究者
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