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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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14 January 2013 |
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Main ID: |
NCT00791830 |
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Date of registration:
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14/11/2008 |
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Primary sponsor: |
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Public title:
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Saving Residual Renal Function Among Haemodialysis Patients Receiving Irbesartan
SAFIR |
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Scientific title:
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Saving Residual Renal Function Among Haemodialysis Patients Receiving Irbesartan - a Double Blind Randomised Study |
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Date of first enrolment:
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April 2009 |
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Target sample size:
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82 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00791830 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Erik Sloth, MD, DrMedSc |
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Address:
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Email:
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Affiliation:
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Department of Anaesthesiology and Intensive Care, Aarhus University Hospital, Skejby, Denmark |
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Name:
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Marija K Novosel, MD |
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Address:
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Email:
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Affiliation:
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Department of Internal Medicine, Region Hospital Fredericia, Denmark |
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Name:
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Ida N Tietze, MD, PhD |
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Address:
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Email:
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Affiliation:
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Department of Internal Medicine, Region Hospital Viborg, Denmark |
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Name:
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Charlotte Strandhave, MD |
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Address:
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Email:
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Affiliation:
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Department of Nephrology, Aalborg University Hospital, Denmark |
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Name:
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Bente Jespersen, MD, DrMedSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Nephrology, Aarhus University Hospital, Skejby, Denmark |
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Name:
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Christian D Peters, MD |
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Address:
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Email:
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Affiliation:
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Department of Nephrology, Aarhus University Hospital, Skejby, Denmark |
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Name:
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Jens Kristian D Jensen, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Nephrology, Aarhus University Hospital, Skejby, Denmark |
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Name:
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Krista D Kjærgaard, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Nephrology, Aarhus University Hospital, Skejby, Denmark |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Kidney Failure, Chronic
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Intervention(s)
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Drug: Irbesartan
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Drug: Placebo matching irbesartan 150 mg
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Primary Outcome(s)
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Decrease in loss of residual kidney function.
[Time Frame: 3, 6, 9 and 12 months]
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Secondary Outcome(s)
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Cardio-vascular outcome assessed by applanation tonometry, echocardiography, Transonic measurements of cardiac output and markers in blood.
[Time Frame: 1 year]
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Progression to anuria
[Time Frame: 3, 6, 9 and 12 months]
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Quality of life assessed by a questionnaire: Kidney Disease Quality Of Life - Short Form (KDQOL-SF)
[Time Frame: 1 year]
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Secondary ID(s)
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EudraCT no: 2008-001267-11
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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