AFX01-13: A Phase 3, Randomized, Active-controlled, Open-label, Multi-center Study of the Safety and Efficacy of AF37702 Injection for the Correction of Anemia in Patients with Chronic Renal Failure (CRF) noton Dialysis and not on Erythropoiesis Stimulating Agent (ESA) Treatment - PEARL 2

AFFYMAX INC.0 个研究点目标入组 450 人开始时间: 2008年7月3日最近更新: 2013年1月7日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: AFFYMAX INC.
入组人数: 450

研究概览入排标准研究者记录与标识符相似试验

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. Patient has been informed of the investigational nature of this study and has given written informed consent in accordance with institutional, local, and national guidelines. 2. Males or females ≥ 18 years of age. 3. Females of child-bearing potential who are sexually active must be willing to practice a highly effective method of birth control for at least 4 weeks prior to randomization, and must be willing to continue contraception until at least 4 weeks after the last dose of study treatment. 4. Chronic Renal Failure with an estimated glomerular filtration rate < 60 mL/min/1.73m2 using the 4-variable Modification of Diet in Renal Disease (MDRD) formula within 4 weeks prior to randomization, and not expected to begin dialysis for at least 12 weeks. 5. Two consecutive Hgb values ≥ 8.0 g/dL and < 11.0 g/dL within 4 weeks prior to randomization, with ≤ 1.3 g/dL difference between the two values and no less than 5 days apart, with the last value within 10 days prior to randomization. 6. One transferrin saturation (TSAT) ≥ 20% or one ferritin level ≥ 100 ng/mL within 4 weeks prior to randomization. 7. One serum or red cell folate level ≥ lower limit of normal during the 4 weeks prior to randomization. 8. One vitamin B12 level ≥ lower limit of normal during the 4 weeks prior to randomization.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

排除标准

•1. Females who are pregnant or breast-feeding. 2. Treatment with an ESA in the 12 weeks prior to randomization. 3. Known intolerance to any ESA, parenteral iron supplementation, or PEGylated molecule. 4. Prior chronic hemodialysis or chronic peritoneal dialysis treatment. (Note: renal transplant patients who are at least 6 months post-transplant and have not had chronic dialysis post-transplant are eligible.) 5. Known bleeding or coagulation disorder. 6. Known hematologic disease or cause of anemia other than renal disease (e.g., pure red cell aplasia (PRCA), homozygous sickle-cell disease, thalassemia, multiple myeloma, hemolytic anemia, myelodysplastic syndrome etc.). 7. Poorly controlled hypertension within 4 weeks prior to randomization, per Investigator's clinical judgment. 8. Any clinically significant medical disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a patient's ability to give informed consent. 9. Evidence of active malignancy within one year prior to randomization. (Note for the purposes of this protocol, active malignancy does not include: non-melanoma skin cancer, carcinoma in situ that has been completely excised, other cancers for which treatment was completed at least one year ago with no continuing treatment and no evidence of metastasis, and other cancers that were diagnosed and treatment completed more than one year ago and within the past year are without evidence of metastasis and treated only with adjuvant hormonal therapy). 10. A scheduled kidney transplant (Note: patients currently on a transplant wait list are not excluded unless there is an identified donor). 11. Scheduled surgery that may be expected to lead to significant blood loss. 12. RBC or whole blood transfusion within 12 weeks prior to randomization. 13. Previous exposure to any investigational agent within 4 weeks prior to randomization, or planned receipt of an investigational agent, other than as specified by this protocol, during the study period. 14. Previous exposure to AF37702 Injection.

研究者

发起方

AFFYMAX INC.

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