EUCTR2006-003173-27-CZ进行中（未招募）不适用
A Multicenter, Randomized, Double-blind Study Comparing De Novo Once Monthly and Once Every 2 Week Darbepoetin alfa Dosing for the Correction of Anemia in Subjects With Chronic Kidney Disease Not Receiving Dialysis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Amgen Ltd
- 入组人数
- 334
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
- •= 18 years of age
- •Diagnosis of chronic kidney disease with eGFR of 15 - 59 mL/min/1.73 m2
- •measured by the following modified Modification of Diet and Renal Disease
- •equation (Levey, 2006):
- •eGFR = 175 x [standardized serum creatinine µmol/L x .0113]-1.154 x [Age in
- •years] 0.203 x [0.742 if subject is female] x [1.212 if subject is black]
- •Clinically stable, in the judgment of the investigator
- •Two consecutive screening Hb values taken at least 7 days apart, and prior to
- •randomization, must each be < 10.0 g/dL
- •Adequate iron stores (TSAT = 15%)
- •Subject is available for protocol-required study visits, to the best of the
- •subject’s and investigator’s knowledge
- •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 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 214
排除标准
- •Scheduled to receive a kidney transplant
- •ESA use within 12 weeks before enrollment
- •Uncontrolled hypertension defined as diastolic BP > 100 mm Hg or systolic BP
- •> 170 mm Hg
- •Acute myocardial ischemia, unstable angina (as determined by the
- •investigator), myocardial infarction; hospitalization for congestive heart failure;
- •stroke or transient ischemic attack; limb ischemia, deep vein thrombosis,
- •thromboembolism, within 12 weeks before enrollment
- •Major surgery within 12 weeks before enrollment (excluding vascular access
- •Currently receiving antibiotic therapy for systemic infection.
- •Known positive HIV antibody or positive hepatitis B surface antigen
- •Evidence of, or received chemotherapy or radiation therapy for, a
- •malignancy within 5 years prior to enrollment, with the following
- •exceptions: localized basal or squamous cell carcinoma of the skin,
- •cervical intraepithelial neoplasia.
- •Red blood cell (RBC) transfusions within 12 weeks before enrollment
- •Androgen therapy within 8 weeks before enrollment
- •Systemic hematological disease (eg, sickle cell anemia, myelodysplastic
- •syndromes, hematologic malignancy; myeloma; hemolytic anemia)
- •Any disorder that may impact (in the judgment of the investigator) the ability to
- •give informed consent for participation in this study
- •Subject of child-bearing potential is evidently pregnant (ie, positive HCG
- •test) or is breast feeding. Subject is not using adequate contraceptive
- •precautions
- •Treatment with an investigational agent or device within 30 days before
- •enrollment or scheduled to receive an investigational agent other than those
- •specified by this protocol during the course of this study
- •Subject has known sensitivity to any of the products to be administered
- •during dosing, including the presence of known neutralizing antierythropoietic
- •protein antibodies
- •Grand mal seizure within 6 months before enrollment
- •Upper or lower GI bleeding within 6 months before enrollment
- •Currently receiving immunosuppressive therapy
研究者
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