NCT01635387

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P50-P75 for phase_4 hypertension

Timeline
Completed

Started Feb 2010

Typical duration for phase_4 hypertension

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 9, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

July 9, 2012

Status Verified

July 1, 2012

Enrollment Period

2.6 years

First QC Date

June 27, 2012

Last Update Submit

July 4, 2012

Conditions

HypertensionEnd Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Aliskiren

EXPERIMENTAL
Drug: aliskiren

Placebo

PLACEBO COMPARATOR
Drug: aliskiren

Interventions

aliskirenDRUG

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

AliskirenPlacebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • years and older.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HypertensionKidney Failure, Chronic

Interventions

aliskiren

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesRenal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 27, 2012

First Posted

July 9, 2012

Study Start

February 1, 2010

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

July 9, 2012

Record last verified: 2012-07