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The Effect of Various Types of the Renin-angiotensin-aldosterone System Blockade on Proteinuria

NCT ID: NCT01541267

Last Updated: 2012-02-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-11-30

Brief Summary

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The main purpose of the study is to compare the effects of three different types of RAAS blockade on 24 hours proteinuria in patients with non-diabetic chronic kidney disease.

Detailed Description

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Pharmacological blockade of the renin-angiotensin-aldosterone system (RAAS) is the main target of therapy to reduces both proteinuria and the rate of decline of the glomerular filtration rate in non-diabetic chronic renal diseases. Despite recent progress, however, there is still no optimal therapy that can stop the progression of these nephropathies. Therefore, it is necessary to optimize such treatment for further improving renal outcome.

The aim of the present study was to compare the effects of three different types of RAAS blockade: (1) mineralocorticoid receptor blocker (MRB) + angiotensin receptor antagonist (ARA); (2) direct renin inhibitor (DRI) + ARA and (3) double maximal dose of ARA on 24 hours proteinuria in patients with non-diabetic chronic kidney disease

Conditions

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Chronic Kidney Disease Proteinuria

Keywords

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aliskiren eplerenon telmisartan direct renin inhibitor ACE inhibitor mineralocorticoid inhibitor proteinuria chronic kidney diseases renin-angiotensin-aldosterone system

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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C - A - B

(A) telmisartan 80 mg + aliskiren 300 mg - (B) telmisartan 80 mg + eplerenon 50 mg - (C) telmisartan 160 mg

Group Type ACTIVE_COMPARATOR

aliskiren, eplerenon, telmisartan

Intervention Type DRUG

aliskiren (Rasilez 300 mg, Novartis Europharm eplerenon (Inspra 50 mg, Pfizer Europe) telmisartan (Micardis 80 mg, Boehringer Ingelheim)

B - A - C

(A) telmisartan 80 mg + aliskiren 300 mg - (B) telmisartan 80 mg + eplerenon 50 mg - (C) telmisartan 160 mg

Group Type ACTIVE_COMPARATOR

aliskiren, eplerenon, telmisartan

Intervention Type DRUG

aliskiren (Rasilez 300 mg, Novartis Europharm eplerenon (Inspra 50 mg, Pfizer Europe) telmisartan (Micardis 80 mg, Boehringer Ingelheim)

A - B - C

(A) telmisartan 80 mg + aliskiren 300 mg - (B) telmisartan 80 mg + eplerenon 50 mg - (C) telmisartan 160 mg

Group Type ACTIVE_COMPARATOR

aliskiren, eplerenon, telmisartan

Intervention Type DRUG

aliskiren (Rasilez 300 mg, Novartis Europharm eplerenon (Inspra 50 mg, Pfizer Europe) telmisartan (Micardis 80 mg, Boehringer Ingelheim)

Interventions

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aliskiren, eplerenon, telmisartan

aliskiren (Rasilez 300 mg, Novartis Europharm eplerenon (Inspra 50 mg, Pfizer Europe) telmisartan (Micardis 80 mg, Boehringer Ingelheim)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* age 18-65 years
* chronic non-diabetic proteinuric nephropathy
* chronic kidney disease stage 1-3
* stable proteinuria above 500 mg/24 hours
* blood pressure above 125/75 mmHg and below 150/95 mmHg
* no steroids or other immunosuppressive treatment for a minimum of six months before the study

Exclusion Criteria

* unstable coronary heart disease
* decompensated congestive heart failure in the previous 6 months
* episode of malignant hypertension or stroke in the history
* diabetes
* creatinine clearance below 30 ml/min
* pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Gdansk

OTHER

Sponsor Role lead

Responsible Party

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Leszek Tylicki

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bolesław Rutkowski, Professor

Role: PRINCIPAL_INVESTIGATOR

Departmen of Nephrology, Transplantation adn Internal Medicine, Medical University of Gdańsk, Poland

Other Identifiers

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ST-4/Aliskiren/2011

Identifier Type: -

Identifier Source: org_study_id