NCT00569101Unknown2 期
A Pilot Study for the Efficacy and Safety of Tacrolimus in the Treatment of Refractory Lupus Nephritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Reducing proteinuria
研究概览
简要总结
The purpose of this protocol is to determine whether Tacrolimus and Prednisolone are effective and safe in the treatment of the cyclophosphamide-resistant, refractory diffuse proliferative lupus nephritis
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy-proven lupus nephritis WHO Class IV , IV+V
- •Previously treated by three times over of i.v. cyclophosphamide or 6 months more duration of immunosuppressive treatments (azathioprine, MMF, cyclophosphamide p.o.) for the lupus nephritis
- •spot urine Protein creatinine raio > 1.0
- •RBC > 5 /HPF on microscopic examination of urine
排除标准
- •previous treatment of cyclosporine A or tacrolimus
- •serum Creatinine lever : over 300 mmol/dl
- •allergy to the macrolide antibiotics
- •other systemic organ damage
研究组 & 干预措施
single
Experimental
single arm study (tacrolimus trial group)
干预措施: tacrolimus (Drug)
结局指标
主要结局
Reducing proteinuria
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Study to Assess the Safety and Efficacy of Tacrolimus (Prograf Capsule/Injection) and Methotrexate (MTX) Combination Therapy for Prevention of Graft Versus Host Disease (GVHD) in Patients Who Received Peripheral Hematopoietic Stem Cell Transplantation From a Sibling DonorGraft Versus Host DiseaseNCT02660684Astellas Pharma Korea, Inc.39
已完成
4 期
Study to Evaluate the Efficacy and Safety of Once-Daily Tacrolimus in Kidney Transplant RecipientsKidney TransplantNCT03749356Chong Kun Dang Pharmaceutical141
已完成
早期 1 期
Sirolimus, Tacrolimus and Short Course Methotrexate for Prevention of Acute GVHD in Recipients of Mismatched Unrelated Donor Allogeneic Stem Cell TransplantationStem Cell TransplantationNCT00612274Yale University26
Unknown
3 期
Efficacy and Safety of Sirolimus in Combination With TacrolimusKidney TransplantationNCT00141804University Hospital Muenster190
招募中
不适用
Tacrolimus Combined With Low-dose Prednisone for Treatment of Myasthenia GravisMyasthenia GravisNCT04768465Da, Yuwei, M.D.160