To Study the Effects of Aliskiren on Albuminuria and Various Biomarkers in Patients With Nephropathy (ARIA)
2012年12月21日 更新者：Novartis Pharmaceuticals
A Single-blind, Double Dummy, Randomized, Multi-dose, Two Sequence, Crossover, Study to Investigate the Effects of Renin Inhibitor (Aliskiren 300 mg) on Albuminuria in Non-diabetic Nephropathy Patients Treated With Ramipril 10 mg and Volume Intervention (ARIA)
The study is designed to primarily assess the effect of aliskiren on albuminuria in patients with non-diabetic nephropathy when treated with ramipril and volume intervention.
研究概览
地位
终止
研究类型
介入性
注册 (实际的)
8
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Groningen、荷兰
- Novartis Investigative Site
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Leeuwarden、荷兰
- Novartis Investigative Site
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Male and female subjects, age 18 years and above
- Patients with chronic kidney disease of non-diabetic origin
- Glomerular filtration rate >30 ml/min/1.73m2
- Patients with a history of hypertension and msSBP (mean systolic blood pressure) of <160 mm Hg and msDBP (mean diastolic blood pressure) <105 mm Hg at screening and baseline.
- Subjects must have a body mass index (BMI) within the range of 18 and 35 kg/m2
Exclusion Criteria:
- Previously treated (within 3 months of screening) with aliskiren or a combination of aliskiren and ramipril.
- Severe hypertension (msDBP ≥110 mmHg and msSBP ≥180 mmHg)
- Pregnant or nursing (lactating) women,
- A medical history of unstable coronary artery disease, myocardial infarction, coronary bypass surgery or cerebrovascular accident within the last six (6) months
- Diabetes mellitus, Heart failure
- High rate of renal function loss
- History of severe hypersensitivity or contraindications to any of the medications or drugs belonging to the similar therapeutic class as the study drugs and the excipients.
- History of liver disease, positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result
- History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
Other protocol-defined inclusion/exclusion criteria applied
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)+HCTZ/Ram+Ali/Ram
Period 1(Day 1 to end of week 6): 1 tablet ramipril 10 mg once daily (o.d.) + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule Hydrochlorothiazide (HCTZ) 25 mg o.d. Period 2 (Weeks 7 to 12): 1 tablet ramipril 10 mg o.d.+ 1 tablet aliskiren 150 mg in 1st week of period; thereafter, 2 tablets aliskiren 150mg o.d.+ 1 capsule HCTZ 25 mg o.d. Period 3 (Weeks 13 to 18): 1 tablet ramipril 10 mg o.d. + 2 tablets aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d. Period 4 (Weeks 19 to 26): 1 tablet ramipril 10 mg o.d. + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d. |
Aliskiren 150 mg (Tablet)
Aliskiren 150 mg Matching Placebo (Tablet)
HCTZ 25mg (Capsule)
HCTZ 25mg (Capsule) Matching Placebo
Ramipril 10mg (Tablet)
|
|
实验性的：Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)/Ram+Ali + HCTZ/Ram
Period 1(Day 1 to end of week 6): 1 tablet ramipril 10 mg once daily (o.d.) + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule Hydrochlorothiazide (HCTZ) 25 mg o.d. Period 2 (Weeks 7 to 12): 1 tablet ramipril 10 mg o.d.+ 1 tablet aliskiren 150 mg in 1st week of period; thereafter, 2 tablets aliskiren 150mg o.d.+ 1 capsule placebo to HCTZ 25 mg o.d. Period 3 (Weeks 13 to 18): 1 tablet ramipril 10 mg o.d. + 2 tablets aliskiren 150mg o.d. + 1 capsule HCTZ 25 mg o.d. Period 4 (Weeks 19 to 26): 1 tablet ramipril 10 mg o.d. + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d. |
Aliskiren 150 mg (Tablet)
Aliskiren 150 mg Matching Placebo (Tablet)
HCTZ 25mg (Capsule)
HCTZ 25mg (Capsule) Matching Placebo
Ramipril 10mg (Tablet)
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Effect of Aliskiren on Albuminuria as Measured by Urinary Albumin Excretion Rate (UAER)
大体时间：26 weeks
|
Two 24-hour collections of urine were to be made at each study visit.
The arithmetic mean of the two collections were planned to be used in the calculation of summary statistics and the statistical analyses.
|
26 weeks
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Effect of Aliskiren on Albuminuria as Measured by Creatinine Indexed Albumin
大体时间：26 weeks
|
Two 24-hour collections of urine were to be made at each study visit.
The arithmetic mean of the two collections were planned to be used in the calculation of summary statistics and the statistical analyses.
|
26 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mean Sitting Systolic Blood Pressure (msSBP)
大体时间：26 weeks
|
At study entry, blood pressure (BP) was measured in both arms.
If there was a clinically relevant difference in readings between arms (≥ 10 mmHg in systolic BP and/or ≥ 5 mmHg in diastolic BP), the arm with higher BP reading was used.
If there was no clinically significant difference between arms, the non-dominant arm was used through out study.
Systolic blood pressure were assessed after the patient rested quietly in the sitting position for at least 3 minutes.
For each sitting assessment, blood pressure was assessed at least 3 times.
From these assessments, msSBP was calculated.
All BP measurements were to be performed on the same arm.
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26 weeks
|
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Mean Sitting Diastolic Blood Pressure (msDBP)
大体时间：26 weeks
|
At study entry, blood pressure (BP) was measured in both arms.
If there was a clinically relevant difference in readings between arms (≥ 10 mmHg in systolic BP and/or ≥ 5 mmHg in diastolic BP), the arm with higher BP reading was used.
If there was no clinically significant difference between arms, the non-dominant arm was used through out study.
Diastolic blood pressure were assessed after the patient rested quietly in the sitting position for at least 3 minutes.
For each sitting assessment, blood pressure was assessed at least 3 times.
From these assessments, msDBP was calculated.
All BP measurements were to be performed on the same arm.
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26 weeks
|
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Mean Glomerular Filtration Rate (GFR) as Measurement of Renal Function
大体时间：26 weeks
|
All patients had to visit the main center for renal function measurements.
The measurements were performed using the constant infusion method with I-iothalamate (IOT) and I-hippuran.
GFR was calculated as the urinary clearance of IOT.
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26 weeks
|
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Mean Effective Renal Plasma Flow (ERPF) as One of Hemodynamic Assessments
大体时间：26 weeks
|
26 weeks
|
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Percentage of Renal Filtration Fraction (RFF) as One of Hemodynamic Assessments
大体时间：26 weeks
|
26 weeks
|
|
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Mean Extracellular Volume (ECV) as One of Hemodynamic Assessments
大体时间：26 weeks
|
26 weeks
|
|
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Plasma Rennin Activity (PRA)
大体时间：Baseline to week 26
|
Blood biomarkers were obtained from blood samples in all patients at the time points such as baseline, week 6, week 12, week 18 and week 26.
Plasma PRA is a direct measure of the formation of Ang I in the plasma.
|
Baseline to week 26
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Plasma Rennin Concentration (PRC)
大体时间：Baseline to week 26
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Blood biomarkers were obtained from blood samples in all patients at the time points such as baseline, week 6, week 12, week 18 and week 26.
PRC measures the concentration of immunoactive renin in the plasma.
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Baseline to week 26
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Number of Participants With Adverse Events, Serious Adverse Events and Death as Assessment of Safety and Tolerability of Aliskiren Added to Ramipril
大体时间：26 weeks
|
26 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年1月1日
初级完成 (实际的)
2011年12月1日
研究完成 (实际的)
2011年12月1日
研究注册日期
首次提交
2011年2月9日
首先提交符合 QC 标准的
2011年2月22日
首次发布 (估计)
2011年2月24日
研究记录更新
最后更新发布 (估计)
2013年1月30日
上次提交的符合 QC 标准的更新
2012年12月21日
最后验证
2012年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.