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.
調査の概要
状態
終了しました
研究の種類
介入
入学 (実際)
8
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
-
Groningen、オランダ
- Novartis Investigative Site
-
Leeuwarden、オランダ
- Novartis Investigative Site
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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)
|
|
実験的：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)
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Effect of Aliskiren on Albuminuria as Measured by Urinary Albumin Excretion Rate (UAER)
時間枠：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
|
|
Effect of Aliskiren on Albuminuria as Measured by Creatinine Indexed Albumin
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mean Sitting Systolic Blood Pressure (msSBP)
時間枠：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.
|
26 weeks
|
|
Mean Sitting Diastolic Blood Pressure (msDBP)
時間枠：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.
|
26 weeks
|
|
Mean Glomerular Filtration Rate (GFR) as Measurement of Renal Function
時間枠：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.
|
26 weeks
|
|
Mean Effective Renal Plasma Flow (ERPF) as One of Hemodynamic Assessments
時間枠：26 weeks
|
26 weeks
|
|
|
Percentage of Renal Filtration Fraction (RFF) as One of Hemodynamic Assessments
時間枠：26 weeks
|
26 weeks
|
|
|
Mean Extracellular Volume (ECV) as One of Hemodynamic Assessments
時間枠：26 weeks
|
26 weeks
|
|
|
Plasma Rennin Activity (PRA)
時間枠：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
|
|
Plasma Rennin Concentration (PRC)
時間枠：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.
PRC measures the concentration of immunoactive renin in the plasma.
|
Baseline to week 26
|
|
Number of Participants With Adverse Events, Serious Adverse Events and Death as Assessment of Safety and Tolerability of Aliskiren Added to Ramipril
時間枠：26 weeks
|
26 weeks
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2011年1月1日
一次修了 (実際)
2011年12月1日
研究の完了 (実際)
2011年12月1日
試験登録日
最初に提出
2011年2月9日
QC基準を満たした最初の提出物
2011年2月22日
最初の投稿 (見積もり)
2011年2月24日
学習記録の更新
投稿された最後の更新 (見積もり)
2013年1月30日
QC基準を満たした最後の更新が送信されました
2012年12月21日
最終確認日
2012年12月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- CSPP100A2260
- 2009-012196-10 (EudraCT番号)
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。