NCT00767221已完成2 期
Oral Treatment With PL-56 in Patients With IgA Nephropathy - an Explorative Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- U-albumin
研究概览
简要总结
The study will investigate the effect of PL-56 on albumin leakage and renal function (glomerular filtration rate) in patients with IgA nephropathy. It will also assess the safety of treatment with PL-56.
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
- •Signed informed consent
- •Female or male patient > 18 years
- •Biopsy-verified IgA nephropathy
- •Proteinuria: U-albumin >500 mg/24 h
- •S-creatinine < 200 umol/L
- •A minimum of four available sample results (U-albumin and S-creatinine) prior to inclusion in the study.
排除标准
- •Severe gastrointestinal disorders which may impair drug effect, or other conditions which could modify the effect of the trial drug as judged by the investigator
- •Consumption of an investigational drug within 30 days prior to enrolment
- •Unacceptable blood pressure (treated or untreated), defined as a systolic value >150 mm Hg and/or diastolic >90 mm Hg
- •Hyperlipidaemia defined as unacceptable levels of lipids according to the discretion of the Investigator
- •Patients in whom an ACE inhibitor was introduced/changed during the last three months prior to enrolment
- •Patients treated with immuno-suppressive drugs
- •Patients unable to take oral medication
- •Severe liver disease (defined as ASAT and/or ALAT and/or gamma-GT above twice the normal value).
- •Uncontrolled (treated or untreated) congestive heart failure as judged by the Investigator
- •Patients with diabetes
- •Patients with current malignancy or history of malignancy during the last three years
- •History or presence of psychological or psychiatric illness which may interfere with the patient´s ability to adhere to the protocol
- •Alcohol or drug abuse (present)
- •Patients unwilling to meet the requirements of the protocol
- •Other medical or social reasons for exclusion at the discretion of the Investigator
- •Use of drugs inhibiting the cytochrome P-450 enzyme CYP3A4 (including grape fruit juice)
- •Kidney transplanted patients
- •For women only: pregnant or breast feeding; unwilling to use adequate contraception during the study (only women of childbearing potential)
研究组 & 干预措施
A
Experimental
The patient is his own control. Endpoint variables are measured before, during and after treatment.
干预措施: Budesonide (Drug)
结局指标
主要结局
U-albumin
时间窗: 6(treatment)+3(follow-up) months
次要结局
- GFR and safety(6(treatment) + 3(follow-up) months)
研究者
研究点 (3)
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