EUCTR2006-001434-41-FR进行中（未招募）1 期
An open-label, randomized, multicenter, parallel group study to demonstrate correction of anemia using once monthly subcutaneous injections of RO0503821 in patients with chronic kidney disease who are not on dialysis - N/A
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 264
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. Written informed consent
- •2. Adult patients (=18 years old) with CKD stage 3 (CrCl/Glomerular filtration rate (GFR) 30-59 mL/min/ 1.73m2) or stage 4 (CrC1/GFR 15-29 mL/min/1.73m2) not requiring dialysis. CrC1/GFR will be estimated at the first screening visit with the Cockcroft-Gault equation or the abbreviated MDRD equation, derived from the full MDRD equation.
- •3. Anemia defined as baseline Hb concentration between 8.0 and 11.0 g/dL determined from the mean of two screening values with at least one day between measurements
- •4. Adequate iron status defined as serum ferritin =100 ng/mL or TSAT =20% (or percentage of hypochromic RBCs <10%) determined from the mean of two screening values with at least one day between measurements
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Need for dialysis therapy expected in the next 6 months or rapid progression of CKD (eg, a CrC1/GFR decrease of more than 20% within 12 weeks)
- •2. Previous therapy with any ESA within 12 weeks prior to the first screening visit or during the screening period. If ESA treatment has been interrupted for at least 12 weeks, the patient may be enrolled in the study. Ongoing ESA treatment should not be discontinued to allow participation in the trial
- •3. Renal allograft in place
- •4. Immunosuppressive therapy (other than corticosteroids for a chronic condition, cyclosporine and monoclonal/polyclonal antibodies) in the 12 weeks before the first screening visit or during the screening period
- •5. Overt gastrointestinal bleeding within 8 weeks before screening or during the screening period
- •6. RBC transfusions within 8 weeks before screening or during the screening period
- •7. Hemoglobinopathies (e.g., homozygous sickle-cell disease, thalassemia of all types)
- •8. Hemolysis
- •9. Active malignant disease (except non-melanoma skin cancer). Patients with malignant disease who have been disease-free for at least the 5 previous years are eligible
- •10. Chronic, uncontrolled or symptomatic inflammatory disease (eg, rheumatoid arthritis, systemic lupus erythematosus)
- •11. Acute infection
- •12. CRP >15 mg/L (measured at screening)
- •13. Vitamin B12 deficiency
- •14. Folic acid deficiency
- •15. Uncontrolled or symptomatic secondary hyperparathyroidism
- •16. Poorly controlled hypertension (sitting SBP =160 mmHg or DBP =100 mmHg – average of two values with at least one day between measurements)
- •17. Epileptic seizure in the 6 months before screening
- •18. Platelets >500 x 10 exp9/L (measured at screening)
- •19. Pure red cell aplasia (PRCA) or history of PRCA
- •20. Chronic congestive heart failure Class IV (New York Heart Association classification)
- •21. High likelihood of early withdrawal or interruption of the study (e.g., myocardial infarction, severe or unstable coronary artery disease, stroke or severe liver disease within the 12 weeks before screening or during the screening period)
- •22. Planned elective surgery during the study period (patients who undergo vascular access surgery, cataract surgery or laser photocoagulation may continue to participate)
- •23. Life expectancy less than 12 months
- •24. Pregnancy or breast-feeding
- •25. Women of childbearing potential without effective contraception
- •26. Administration of another investigational drug within 4 weeks before screening or planned during the study period
- •27. Known hypersensitivity to any constituents of the study or reference drug formulations
- •28. Previous treatment with RO0503821
研究者
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