EUCTR2007-000443-99-DE进行中（未招募）不适用
Comparison of the sequential maintenance therapy with Mycophenolat and Prednisolon to standard therapy after completed induction therapy – a multicenter, randomised, phase III intervention study for progressive IgA-Nephritis
niversitätsklinikum Ulm0 个研究点开始时间: 2008年11月13日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •- Age > 18 years and < 65 years,
- •- gender: male and female
- •- mesangioproliferative IgA nephritis, histological confirmed
- •- < 30% of the glomeruli with extracapillary semilunars
- •- Progressive form of IgA-Nephritis before start of the clinical trial
- •- With formely normal renal function: Creatinine increase of > 25% or GFR loss of >20% over at least 1-2 years after diagnosis
- •- With formerly impaired renal function: Creatinine>130 µmol/l and GFR <60 ml/min respectively: ongiong continous GFR loss within 5 months
- •- MDRD-2 GFR < 60ml/min and Creatinine > 130 µmol/ after induction therapy respectively
- •- Henoch-Schönlein purpura with IgA nephritis if ongoing progression after 12 months
- •- Completed induction therapy
- •- Proteinuria-creatinine ratio > 3.5
- •- Nephrotic syndrome after induction therapy
- •- Supportive therapy with ACEi (at least 10 mg Enalapril or equivalent) or/and ARB (at least 300 mg Irbesartan or equivalent) and comparable anti-hypertensive drugs if hypertensivity
- •- female patients with childbearing potential: negative urine pregnancy test before the start of the clinical trial and one of the following, medically accepted contraceptive methods during the whole clinical trial and at least 6 weeks after the last medication intake: surgical sterility, double barrier methods, intrauterine contraceptive device, lifestyle with a personal choice of abstinence, vasectomy of sexual partner at least 3 months prior to enrolment in combination with barrier methods or must be at least two years postmenopausal.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Secondary IgA nephritis (such as lupus nephritis, liver cirrhoses)
- •- Extracapillary proliferative Nephritis in > 30% of the glomerula
- •- GFR>60ml/min after induction therapy (Creatinine <130 µmol/l)
- •- Creatinine > 400 µmol/l after induction therapy in the majority of at least 3 measurements
- •- Systolic blood pressure >140 mmHg in the majority of at least 3 measurements
- •- Missing informed consent
- •- Other exclusion criteria such as malignant tumor, pregnancy or significant co-morbiditiy according to the waiting list for renal transplant
- •- Hypersensitivity to Mycophenolate sodium, Mycophenolic acid or Mycophenolate mofetil or any other compound of Myfortic® (see SmPC appendix 15.5.)
- •- Any of the following medications:
- •- Bile acid binding drugs or therapies, cholestyramine, orally given activated charcoal
- •- Any drugs containing magnesium
- •- Ganciclovir, Aciclovir (without medical supervision)
- •- Vitamin D or ist derivatives, except for Decostriol®
- •- 8 weeks prior vaccination or 2 weeks after vaccination
- •- Active viral infection
- •- HBsAG positive chronic active hepaitis
- •- Lymphadenitis after BCG vaccination
- •- Hypersensivity to Prednisolon (Decortin H®) or to any of the other components of Decortin H®
- •- Hereditary fructose intolerance, hypoxanthine guanine phosphoribosyltransferase deficiency, galactose intolerance, lactase deficiency, glucose-galactose malabsorption
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