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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 14 January 2013
Main ID:  NCT00791830
Date of registration: 14/11/2008
Primary sponsor: University of Aarhus
Public title: Saving Residual Renal Function Among Haemodialysis Patients Receiving Irbesartan SAFIR
Scientific title: Saving Residual Renal Function Among Haemodialysis Patients Receiving Irbesartan - a Double Blind Randomised Study
Date of first enrolment: April 2009
Target sample size: 82
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00791830
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention  
Countries of recruitment
Denmark
Contacts
Name:   Erik Sloth, MD, DrMedSc
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Affiliation:  Department of Anaesthesiology and Intensive Care, Aarhus University Hospital, Skejby, Denmark
Name:   Marija K Novosel, MD
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Affiliation:  Department of Internal Medicine, Region Hospital Fredericia, Denmark
Name:   Ida N Tietze, MD, PhD
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Affiliation:  Department of Internal Medicine, Region Hospital Viborg, Denmark
Name:   Charlotte Strandhave, MD
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Affiliation:  Department of Nephrology, Aalborg University Hospital, Denmark
Name:   Bente Jespersen, MD, DrMedSc
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Affiliation:  Department of Nephrology, Aarhus University Hospital, Skejby, Denmark
Name:   Christian D Peters, MD
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Affiliation:  Department of Nephrology, Aarhus University Hospital, Skejby, Denmark
Name:   Jens Kristian D Jensen, MD, PhD
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Affiliation:  Department of Nephrology, Aarhus University Hospital, Skejby, Denmark
Name:   Krista D Kj√¶rgaard, MD, PhD
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Affiliation:  Department of Nephrology, Aarhus University Hospital, Skejby, Denmark
Key inclusion & exclusion criteria

Inclusion Criteria:

- Haemodialysis patient

- Haemodialysis treatment for maximum 12 months

- > 18 years old

- informed consent

- urine volume > 300 ml / 24 hours

- contraception if fertile woman

Exclusion Criteria:

- Systolic blood pressure < 110 mm Hg

- Able to comprehend the aims of the project and follow instructions

- Allergy to irbesartan/ACE-inhibitors/ARBs

- Myocardial infarction or unstable angina pectoris during the last 3 months

- Ejection fraction < 30 %

- Pregnancy



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Kidney Failure, Chronic
Intervention(s)
Drug: Irbesartan
Drug: Placebo matching irbesartan 150 mg
Primary Outcome(s)
Decrease in loss of residual kidney function. [Time Frame: 3, 6, 9 and 12 months]
Secondary Outcome(s)
Cardio-vascular outcome assessed by applanation tonometry, echocardiography, Transonic measurements of cardiac output and markers in blood. [Time Frame: 1 year]
Progression to anuria [Time Frame: 3, 6, 9 and 12 months]
Quality of life assessed by a questionnaire: Kidney Disease Quality Of Life - Short Form (KDQOL-SF) [Time Frame: 1 year]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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