To Study the Effects of Aliskiren on Albuminuria and Various Biomarkers in Patients With Nephropathy (ARIA)
2012년 12월 21일 업데이트: 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.
연구 개요
상태
종료됨
연구 유형
중재적
등록 (실제)
8
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Groningen, 네덜란드
- Novartis Investigative Site
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Leeuwarden, 네덜란드
- Novartis Investigative Site
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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)
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실험적: 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)
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Effect of Aliskiren on Albuminuria as Measured by Urinary Albumin Excretion Rate (UAER)
기간: 26 weeks
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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.
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26 weeks
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Effect of Aliskiren on Albuminuria as Measured by Creatinine Indexed Albumin
기간: 26 weeks
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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.
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26 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Mean Sitting Systolic Blood Pressure (msSBP)
기간: 26 weeks
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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)
기간: 26 weeks
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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
기간: 26 weeks
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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
기간: 26 weeks
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26 weeks
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Percentage of Renal Filtration Fraction (RFF) as One of Hemodynamic Assessments
기간: 26 weeks
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26 weeks
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Mean Extracellular Volume (ECV) as One of Hemodynamic Assessments
기간: 26 weeks
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26 weeks
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Plasma Rennin Activity (PRA)
기간: 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.
Plasma PRA is a direct measure of the formation of Ang I in the plasma.
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Baseline to week 26
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Plasma Rennin Concentration (PRC)
기간: 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
기간: 26 weeks
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26 weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2011년 1월 1일
기본 완료 (실제)
2011년 12월 1일
연구 완료 (실제)
2011년 12월 1일
연구 등록 날짜
최초 제출
2011년 2월 9일
QC 기준을 충족하는 최초 제출
2011년 2월 22일
처음 게시됨 (추정)
2011년 2월 24일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2013년 1월 30일
QC 기준을 충족하는 마지막 업데이트 제출
2012년 12월 21일
마지막으로 확인됨
2012년 12월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CSPP100A2260
- 2009-012196-10 (EudraCT 번호)
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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