EUCTR2016-002262-31-GB进行中（未招募）1 期
A Phase II Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in IgA Nephropathy
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Merck KGaA
- 入组人数
- 50
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
- •For inclusion in the study, all of the following inclusion criteria must be fulfilled:
- •1. =18 years of age
- •2. Biopsy-proven IgA nephropathy
- •3. Proteinuria 1 to 6 g/day
- •4. Stable and optimal dose of ACE inhibitor and/or ARB at least 8 weeks prior to screening
- •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 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1. Concomitant significant renal disease other than IgA nephropathy
- •2. IgA nephropathy with significant glomerulosclerosis or cortical scarring
- •3. Diagnosis of Henoch-Schonlein purpura
- •4. Meets eGFR and biopsy requirement criteria
- •5. Serum IgG below 6 g/L
- •6. Use of cyclophosphamide ever or use of other immunosuppressants or systemic corticosteroids within 4 months
- •7. Active infection requiring hospitalization or treatment with parenteral anti-infectives within 4 weeks
- •8. History, or current diagnosis, of active tuberculosis (TB), or untreated latent TB infection
- •9. History of or positive HIV and/or positive for hepatitis B or Hepatitis C at screening
- •10. History of malignancy
- •11. Nursing or pregnancy
- •12. Any condition, including any uncontrolled disease state other than IgA nephropathy.
研究者
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