EUCTR2012-001923-11-IT进行中（未招募）不适用
A Multicentre, Interventional treatment, Randomised, Double-Blind, Single Group Assignment Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon in primary IgA nephropathy patients at risk of developing end-stage renal disease - NEFIGAN Trial
CROWN OY0 个研究点目标入组 200 人开始时间: 2012年9月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
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
- •1.Female or male patients =18 years
- •2.Biopsy-verified IgA nephropathy
- •3.Urine protein creatinine ratio =0.5 g/g (56.5 mg/mmol)
- •4.eGFR =50 mL/min per 1.73 m2 using CKD-EPI formula
- •5.Willing to change antihypertensive medication regimen if applicable
- •6.Willing and able to give informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1.Secondary forms of IgA nephropathy as defined by the treating physician (for example, Henoch–Schönlein purpura patients and those with associated alcoholic cirrhosis)
- •2.Presence of crescent formation in =50% of glomeruli assessed on renal biopsy
- •3.Kidney transplanted patients
- •4.Severe gastrointestinal disorders (including peptic ulcer disease and inflammatory bowel disease) which may impair drug effect, or other conditions which could modify the effect of the trial drug as judged by the Investigator
- •5.Consumption of an investigational drug within 30 days prior to enrolment
- •6.Hyperlipidaemia defined as unacceptable levels of lipids according to the discretion of the Investigator
- •7.Morbid obesity defined as a body mass index (BMI) >45 kg/m2
- •8.Patients currently treated with systemic immunosuppressive or systemic corticosteroid drugs (excluding topical or nasal steroids) or have been previously treated for more than one week within the last 24 months.
- •9.Patients currently treated chronically (daily dosing) with inhaled corticosteroid drugs or have previously been treated chronically for more than one month within the last 12 months
- •10.Patients previously treated with immunosuppressive or systemic corticosteroids for the treatment of IgA nephropathy
- •11.Patients unable to take oral medication or intolerant to budesonide or other corticosteroid preparations
- •12.Patients with known allergy or intolerance to ACEI, ARB or to any component of the trial drug formulation
- •13.Patients with acute or chronic infectious disease incl. hepatitis, HIV positive patients and patients with chronic urinary tract infections
- •14.Severe liver disease according to the discretion of the Investigator
- •15.Patients with Type 1 or 2 diabetes
- •16.Patients with uncontrolled cardiovascular disease as judged by the Investigator
- •17.Patients with current malignancy or history of malignancy during the last three years
- •18.History or presence of psychological or psychiatric illness (including steroid induced psychosis) which may interfere with the patient´s ability to adhere to the protocol
- •19.Patients with untreated osteoporosis
- •20.Patients with glaucoma or cataract
- •21.Alcohol or drug abuse (present)
- •22.Patients unwilling to meet the requirements of the protocol
- •23.Other medical or social reasons for exclusion at the discretion of the Investigator
- •24.Life expectancy < 1 year
- •25.For women only; pregnant or breast feeding or unwilling to use adequate contraception during the trial (only women of child bearing potential
研究者
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