RAAS Inhibitor Drugs in Dialysis Patients | NCT01635387

Studies
RAAS Inhibitor Drugs in Dialysis Patients

NCT01635387

Sponsor

University of Campania Luigi Vanvitelli

Status

Unknown status

Last Update Posted

Jul 9, 2012Estimated

Enrollment

350Estimated

Phase

Phase 4

Conditions

Hypertension
End Stage Renal Disease

Interventions

aliskiren

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2010

Primary Completion Date

Sep 2012Estimated

Completion Date

Sep 2012Estimated

First Submitted Date

Jun 27, 2012

First Submission Date that Met QC Criteria

Jul 4, 2012

First Posted Date

Jul 9, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 4, 2012

Last Update Posted Date

Jul 9, 2012Estimated

Name	Class
IRCCS San Raffaele	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

350Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Aliskiren	Experimental		Drug: aliskiren
Placebo	Placebo Comparator		Drug: aliskiren

Interventions

Name	Type	Description	Arm Group Labels	Other Names
aliskiren	Drug	150 mg once a day per 2 week with forced uptitration to 300 mg once a day, if tolerated	Aliskiren Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
time to first clinical event (among mortality from any cause, cardiac event including myocardial infarction, need for coronary angioplasty or coronary bypass surgery, ischaemic stroke, new-onset heart failure, new-onset atrial fibrillation)		30 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension
D007676	Kidney Failure, Chronic

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C446481	aliskiren

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided