NCT00396721已完成2 期
Pilot Trial of Treatment of Poor-Prognosis IgA Nephropathy With Low Exposure to Sirolimus.
Josep m Cruzado1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2006年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- To evaluate the effect of the administration of Rapamune on a clinical composite variable (change in proteinuria, blood pressure and hematuria) in patients with IgA nephropathy with poor prognosis criteria
研究概览
简要总结
The purpose of this study is to test in a pilot trial the efficacy and tolerance of sirolimus oral (at low doses) in patient to treat poor-prognosis IgA Nephropathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 70 and with capacity to grant informed consent
- •Biopsy-proven IgA nephropathy by means of standard immunohistochemical and morphological criteria
- •Renal biopsy in the in the 3 months prior to randomization date
- •Absence of known hepatic, cardiac, pulmonary or intestinal disease
- •Glomerular filtrate estimated by Cockcroft-Gault, more than 30 ml/min
- •Any of the following clinical states: a) High blood pressure defined as systolic blood pressure higher than 140 mmHg or diastolic blood pressure higher than 90 mmHg associated with proteinuria between 0.3-1 g/day and/or microhematuria. b) Proteinuria higher than 1g/day
- •Women of child-bearing age will follow a suitable contraceptive method, and a negative pregnancy test will be needed before inclusion in the study
排除标准
- •Serology positive for HIV or hepatitis B infection (defined as positive for the HbsAg antigen) or hepatitis C infection (defined as viral RNA detection)
- •Treatment with steroids or immunosuppressors in the two previous years
- •Evidence of active infection at the time of inclusion in the study
- •Pregnancy or breastfeeding at the time of inclusion in the study
- •Estimated glomerular filtration < 30 ml/min, bilirubin > 2 mg/dl, or ALT or AST two times higher than the normal upper limit
- •Diabetes Mellitus, defined as patients treated with insulin or oral antidiabetics or glycemias higher than 140 mg/dl in two or more episodes
- •Poor control of high blood pressure (defined as systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 100 mm Hg, taking 3 or more antihypertensives) or evidence or suspicion of renovascular disease
- •Thrombocytopenia less than 100,000 /mm3 or total neutrophil value lower than 2000 /mm3 or triglycerides value > 400 mg/dL (4.6 mmol/L) or cholesterol > 300 mg/dL (7.8 mmol/L) or LDL > 200 mg/dL
- •IgA nephropathy systemic forms, i.e., Schönlein-Henoch purpura, IgA nephropathy secondary forms, post-renal transplant IgA nephropathy recurrences, cases presented in the form of rapidly progressive renal failure and cases with the presence of cellular crescents in more than 50% of the glomeruli will be excluded
- •History of cancer in the previous 5 years,exception of skin basocellular carcinoma and uterine in situ carcinoma (completely removed both of them)
- •Know intolerance to Sirolimus or macrolides
研究组 & 干预措施
A
Active Comparator
干预措施: ACE inhibitor + statin (Drug)
B
Experimental
干预措施: Sirolimus (study drug)+ACE inhibitor + statin (Drug)
结局指标
主要结局
To evaluate the effect of the administration of Rapamune on a clinical composite variable (change in proteinuria, blood pressure and hematuria) in patients with IgA nephropathy with poor prognosis criteria
时间窗: at month 12th
次要结局
- Change in the glomerular filtrate rate evaluated by means of radionuclide techniques (51Cr-EDTA) and comparison between both arms(At months 6th and 12th)
- Change in renal histology(At 12 months)
- Percentage of patients who withdraw from the study medication due to adverse events(Within 1 year)
- Percentage of patients with therapeutic failure(Within 1 year)
研究者
Josep m Cruzado
Nephrologist
Hospital Universitari de Bellvitge
研究点 (1)
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