Saving Residual Renal Function Among Haemodialysis Patients Receiving Irbesartan
SAFIR
1 other identifier
interventional
82
1 country
6
Brief Summary
Angiotensin II receptor blockers (ARB) are known to preserve kidney function among patients with kidney diseases and reduced renal function, but not among haemodialysis patients. Haemodialysis patients often lose residual renal function after initiating dialysis leading to worsened quality of life, increased morbidity and mortality. In this study an ARB is investigated in a double blind, randomised, parallel group, placebo controlled manner to see, if this ARB can save residual renal function among haemodialysis patients. Potential cardiovascular benefits of the treatment are also addressed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2009
Typical duration for phase_3
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2008
CompletedFirst Posted
Study publicly available on registry
November 17, 2008
CompletedStudy Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedJanuary 8, 2013
January 1, 2013
3.8 years
November 14, 2008
January 7, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Decrease in loss of residual kidney function.
3, 6, 9 and 12 months
Secondary Outcomes (3)
Cardio-vascular outcome assessed by applanation tonometry, echocardiography, Transonic measurements of cardiac output and markers in blood.
1 year
Progression to anuria
3, 6, 9 and 12 months
Quality of life assessed by a questionnaire: Kidney Disease Quality Of Life - Short Form (KDQOL-SF)
1 year
Study Arms (2)
Irbesartan
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Tablets, 300 mg \* 1 daily, 1 year
Eligibility Criteria
You may qualify if:
- Haemodialysis patient
- Haemodialysis treatment for maximum 12 months
- \> 18 years old
- informed consent
- urine volume \> 300 ml / 24 hours
- contraception if fertile woman
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Department of Nephrology, Aarhus University, Aalborg
Aalborg, 9000, Denmark
Department of Nephrology, Aarhus University Hospital, Skejby
Aarhus N, 8200, Denmark
Department of Medicine, Fredericia Hospital
Fredericia, 7000, Denmark
Haemodialysis unit, Horsens Hospital
Horsens, 8700, Denmark
Hemodialysis Unit, Randers Hospital
Randers, 8600, Denmark
Department of Medicine M, Viborg Hospital
Viborg, 8800, Denmark
Related Publications (3)
Peters CD, Kjaergaard KD, Christensen KL, Bibby BM, Jespersen B, Jensen JD. High-sensitivity Troponin T in hemodialysis patients: a randomized placebo-controlled sub-study investigating angiotensin-II-blockade, variation over time and associations with clinical outcome. BMC Nephrol. 2020 Oct 28;21(1):452. doi: 10.1186/s12882-020-02103-1.
PMID: 33115436DERIVEDPeters CD, Kjaergaard KD, Jensen JD, Christensen KL, Strandhave C, Tietze IN, Novosel MK, Bibby BM, Jespersen B. Short and Long-Term Effects of the Angiotensin II Receptor Blocker Irbesartan on Intradialytic Central Hemodynamics: A Randomized Double-Blind Placebo-Controlled One-Year Intervention Trial (the SAFIR Study). PLoS One. 2015 Jun 1;10(6):e0126882. doi: 10.1371/journal.pone.0126882. eCollection 2015.
PMID: 26030651DERIVEDPeters CD, Kjaergaard KD, Jespersen B, Christensen KL, Jensen JD. Renal and cardiovascular effects of irbesartan in dialysis patients--a randomized controlled trial protocol (SAFIR study). Dan Med J. 2013 Apr;60(4):A4602.
PMID: 23651713DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Bente Jespersen, MD, DrMedSc
Department of Nephrology, Aarhus University Hospital, Skejby, Denmark
- STUDY CHAIR
Erik Sloth, MD, DrMedSc
Department of Anaesthesiology and Intensive Care, Aarhus University Hospital, Skejby, Denmark
- STUDY CHAIR
Jens Kristian D Jensen, MD, PhD
Department of Nephrology, Aarhus University Hospital, Skejby, Denmark
- STUDY DIRECTOR
Krista D Kjærgaard, MD, PhD
Department of Nephrology, Aarhus University Hospital, Skejby, Denmark
- STUDY CHAIR
Christian D Peters, MD
Department of Nephrology, Aarhus University Hospital, Skejby, Denmark
- PRINCIPAL INVESTIGATOR
Charlotte Strandhave, MD
Department of Nephrology, Aalborg University Hospital, Denmark
- PRINCIPAL INVESTIGATOR
Ida N Tietze, MD, PhD
Department of Internal Medicine, Region Hospital Viborg, Denmark
- PRINCIPAL INVESTIGATOR
Marija K Novosel, MD
Department of Internal Medicine, Region Hospital Fredericia, Denmark
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2008
First Posted
November 17, 2008
Study Start
April 1, 2009
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
January 8, 2013
Record last verified: 2013-01