EUCTR2017-004372-56-GB进行中（未招募）1 期
A Phase 3 randomized, double-blind, active-controlled, parallel-group, multi-center study in hemodialysis participants with anemia of chronic kidney disease to evaluate the efficacy, safety and pharmacokinetics of three-times weekly dosing of daprodustat compared to recombinant human erythropoietin, following a switch from recombinant human erythropoietin or its analogs.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 402
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
- •1. Age: Participant must be 18 to 99 years of age inclusive, at the time of signing the informed consent.
- •Note: Country-specific age requirements for Korea are provided in Appendix 8, Section 12.8.2 of the study protocol
- •2. RhEPO or its analogs: Use of any approved rhEPO or analog for at least 8 weeks
- •prior to the screening visit and continuing during the screening period until randomization (Day 1).
- •3. Hemoglobin concentration (measured by HemoCue) within the following range:
- •Week -4: Hgb 8 to 11.5 g/dL1 (5 to 7.1 mmol/ L).
- •If Hgb is 11.6 to 11.9 g/dL2 (7.2 to 7.4 mmol/L), up to two retests are allowed; the retest value must be between 8 to 11.5 g/dL1 (5 to 7.1 mmol/ L).
- •Day 1: Hgb 8 to 11 g/dL1 (5 to 6.8 mmol/L) and receiving at least the minimum rhEPO or analog dose 3.
- •Hgb >11 to 11.5 g/dL1 (6.8 to 7.1 mmol/L) and receiving greater than the minimum rhEPO or analog dose 3.
- •4. Dialysis: On hemodialysis (including hemofiltration or hemodiafiltration) >90 days prior to screening and continuing during the screening period.
- •5. Frequency of Dialysis: On hemodialysis (in-center) =3 times per week.
- •6. Sex: Male and female participants are eligible. A female participant is eligible to participate if she is not pregnant (see Appendix 4), not breastfeeding, and at least one of the following conditions applies:
- •Not a woman of childbearing potential (WOCBP) as defined in Appendix 4 of the study protocol, or
- •A WOCBP who agrees to follow the contraceptive guidance in Appendix 4 of the study protocol from at least 28 days prior to first dose of study treatment and for at least 28 days after the last dose of study treatment.
- •7. Informed Consent: Capable of giving signed informed consent as described in
- •Appendix 2 of the study protocol which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the study protocol.
- •Note: Country-specific requirements for France for the informed consent process are provided in Appendix 8 of the study protocol (see Section 12.8.1, Item 3 for details).
- •8. Other Study Eligibility Criteria Consideration: In France, a participant will be
- •eligible for inclusion in this study if he or she is either affiliated to or beneficiary of a social security category.
- •Note: Country-specific requirements for France for inclusion in this study are
- •provided in Appendix 8 of the study protocol (see Section 12.8.1 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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 202
排除标准
- •CKD Related Criteria
- •1. Kidney transplant: Planned living-related or living-unrelated kidney transplant
- •within 52 weeks after randomization (Day 1).
- •Anemia Related Criteria
- •2. Ferritin: =100 ng/mL (=100 µg/L), at screening.
- •3. Transferrin saturation (TSAT): =20%, at screening. If TSAT is 18 to 20%, then a
- •retest using a new blood sample can be obtained within 7 days of the final laboratory report; the final retest value must be >20% to confirm eligibility.
- •4. Aplasias: History of bone marrow aplasia or pure red cell aplasia.
- •5. Other causes of anemia: Conditions, other than anemia of CKD, which can affect erythropoiesis. A partial list can be found in the Study Reference Manual (SRM).
- •Cardiovascular Disease
- •6. MI or acute coronary syndrome within 8 weeks prior to screening through to
- •randomization (Day 1).
- •7. Stroke or transient ischemic attack within 8 weeks prior to screening through to randomization (Day 1).
- •8. Heart failure (HF): Chronic Class IV HF, as defined by the New York Heart
- •Association (NYHA) functional classification system.
- •9. Current uncontrolled hypertension as determined by the investigator that would contraindicate the use of rhEPO.
- •10. Bazett’s correction of QTc interval (QTcB) at Day 1: QTcB >500 msec, or QTcB
- •>530 msec in participants with bundle branch block. There is no QTc exclusion for
- •participants with a predominantly ventricular paced rhythm.
- •Other Medical Conditions
- •11. Liver Disease: presence of any one of the following liver-related laboratory values or conditions, at screening, is exclusionary:
- •Alanine transaminase (ALT) >2x upper limit of normal (ULN);
- •Bilirubin >1.5x ULN; or
- •NOTE: Isolated bilirubin >1.5x ULN 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 participant otherwise meets entry criteria.
- •12. Gastrointestinal (GI) bleeding: Evidence of actively bleeding gastric, duodenal or esophageal ulcer disease OR clinically significant GI bleeding = 8 weeks prior to
- •screening through to randomization (Day 1).
- •13. Malignancy: History of malignancy within 2 years prior to screening through to randomization (Day 1), currently receiving treatment for cancer, or complex kidney cyst (e.g., Bosniak Category IIF, III or IV) >3 cm.
- •Note: The only exception is localized squamous cell or basal cell carcinoma of the
- •skin that has been definitively treated =8 weeks prior to screening.
- •Prior/Concomitant Therapy
- •14. Drugs and supplements: Use of a strong inhibitor of CYP2C8 (e.g., gemfibrozil) or a strong inducer of CYP2C8 (e.g., rifampin/rifampicin).
- •Prior/Concurrent Clinical Study Experience
- •15. Severe allergic reactions: History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product (refer to daprodustat IB), or epoetin alfa (refer to product labeling).
- •16. Other interventional study participation: Use of another investigational agent
- •within 30 days or within five half-lives of the investigational agent (whichever is
- •longer) or currently participating in a study of an investigational device prior to
- •screening through to randomization (Day
研究者
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