Eitner Frank, Ackermann Diana, Hilgers Ralf-Dieter, Floege Jürgen
Division of Nephrology and Immunology, RWTH University of Aachen, Aachen, Germany.
J Nephrol. 2008 May-Jun;21(3):284-9.
The best treatment of IgA nephropathy (IgAN) is currently not well defined. The Supportive Versus Immunosuppressive Therapy of Progressive IgA Nephropathy (STOP IgAN) trial aims to answer if, in IgAN patients, an immunosuppressive treatment is more effective than a supportive treatment.
In a randomized prospective multicenter study (www.clinicaltrials.gov, NCT00554502), we will treat 148 patients at risk for progressive IgA nephropathy following a 6-month run-in phase, in 2 groups: (group a) supportive treatment: patients with a persistent proteinuria >0.75 g/day will receive a maximized therapy to reduce blood pressure and urinary protein loss using angiotensin-converting enzyme inhibitors and AT1 blockers, statins, dietary counseling for a low-sodium and low-protein diet and education/intervention programs to stop smoking. (group b) immunosuppressive treatment: in addition to the identical treatment of group a, patients will receive treatment with steroids (glomerular filtration rate [GFR] > or =60 ml/min) or steroids plus cyclophosphamide/azathioprine (GFR <60 ml/min). Study end points are the complete remission of the disease and the individual degree of renal functional loss. If the immunosuppressive therapy shows a superior efficacy with respect to prevention of renal failure, the potentially higher therapy cost and risk might be justified. Finally, our trial can serve as a model for various other types of glomerulonephritis, for which such trials are very difficult to perform, given their infrequency.
目前，IgA肾病（IgAN）的最佳治疗方法尚未明确界定。进行性IgA肾病支持治疗与免疫抑制治疗（STOP IgAN）试验旨在回答在IgAN患者中，免疫抑制治疗是否比支持治疗更有效。
在一项随机前瞻性多中心研究（www.clinicaltrials.gov，NCT00554502）中，我们将在6个月的导入期后，将148例有进行性IgA肾病风险的患者分为两组进行治疗：（A组）支持治疗：持续性蛋白尿>0.75 g/天的患者将接受最大化治疗，使用血管紧张素转换酶抑制剂和AT1受体阻滞剂、他汀类药物降低血压和减少尿蛋白丢失，接受低钠和低蛋白饮食的饮食咨询以及戒烟教育/干预项目。（B组）免疫抑制治疗：除了与A组相同的治疗外，患者将接受类固醇治疗（肾小球滤过率[GFR]≥60 ml/分钟）或类固醇加环磷酰胺/硫唑嘌呤治疗（GFR<60 ml/分钟）。研究终点为疾病完全缓解和肾功能丧失的个体程度。如果免疫抑制治疗在预防肾衰竭方面显示出更高的疗效，那么潜在的更高治疗成本和风险可能是合理的。最后，我们的试验可以作为各种其他类型肾小球肾炎的模型，鉴于这些疾病发病率低，进行此类试验非常困难。
