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RAAS Inhibitor Drugs in Dialysis Patients

NCT ID: NCT01635387

Last Updated: 2012-07-09

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-09-30

Brief Summary

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Hypertensive haemodialysis patients are at high risk for cardiovascular events. This study was undertaken to ascertain whether the upstream of aliskirne, a direct renin inhibitor improves mortality and cardiovascular outcomes in these high-risk population.

Detailed Description

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Conditions

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Hypertension End Stage Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Aliskiren

Group Type EXPERIMENTAL

aliskiren

Intervention Type DRUG

150 mg once a day per 2 week with forced uptitration to 300 mg once a day, if tolerated

Placebo

Group Type PLACEBO_COMPARATOR

aliskiren

Intervention Type DRUG

150 mg once a day per 2 week with forced uptitration to 300 mg once a day, if tolerated

Interventions

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aliskiren

150 mg once a day per 2 week with forced uptitration to 300 mg once a day, if tolerated

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* chronic kidney disease stage 5
* undergoing maintenance haemodialysis for a minimum of 3 months
* existing arterial hypertension or
* history of arterial hypertension or
* resting blood pressure ≥140/90 mmHg or
* antihypertensive medication
* man and female
* 18 years and older.

Exclusion Criteria

* recent myocardial infarction (less than 3 months)
* atrial fibrillation/atrial flutter
* hypotension with systolic blood pressure of \<90 mmHg
* high-grade aortic stenosis
* left ventricular ejection fration \<50%
* known allergy to aliskiren
* severe disorders of liver function
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS San Raffaele

OTHER

Sponsor Role collaborator

University of Campania Luigi Vanvitelli

OTHER

Sponsor Role lead

Responsible Party

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Gennaro Cice

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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RAAS-block dial

Identifier Type: -

Identifier Source: org_study_id