Saving Residual Renal Function Among Haemodialysis Patients Receiving Irbesartan (SAFIR)
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| ClinicalTrials.gov Identifier: NCT00791830 |
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Recruitment Status :
Completed
First Posted : November 17, 2008
Last Update Posted : January 8, 2013
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Kidney Failure, Chronic | Drug: Irbesartan Drug: Placebo matching irbesartan 150 mg | Phase 3 |
Haemodialysis patients often lose residual renal function rather quickly after initiation of dialysis - average loss is 30 % per year. Loss of residual kidney function leads to deteriorating quality of life, more morbidity and a higher mortality. Many causes to this has been identified, but no one has - to my knowledge - addressed saving of residual renal function among haemodialysis patients so far.
Hypothesis: Irbesartan can reduce loss of residual kidney function among haemodialysis patients and left ventricular hypertrophy and arterial stiffness is less pronounced after 1 year of treatment.
Methods: 80 patients are randomised to receive either irbesartan, an angiotensin II receptor blocker (ARB), or placebo for 1 year. Residual renal function will be estimated before and one-two weeks after initiating project medicine, in order to estimate the acute effect of ARB on residual renal function in this study population. Thereafter, glomerular filtration rate (GFR) and urine volume will be determined after 3, 6, 9 and 12 months giving a regression line for each patient. 8 dialysis units will be recruiting patients.
Investigations:
- creatinine-urea-clearance by 24h urine collection
- applanation tonometry
- cardiac output
- echocardiography
- QoL questionnaire
- endocrinological and cardiovascular markers in blood and urine
Perspectives: It is well-known that ceased urine production has a tremendous negative effect on the quality of life of haemodialysis patients. Lately it was shown that residual renal function has greater impact than dialysis dose on morbidity as well as mortality. Among peritoneal dialysis patients in Asia an angiotensin-converting enzyme inhibitors (ACEI) or an ARB saved residual renal function, but preservation of renal function has not been addressed in haemodialysis patients, and ACEI or ARB are only prescribed to roughly 15 % of these.
If this study confirms our hypothesis the growing population of haemodialysis patients should be offered irbesartan.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 82 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | Saving Residual Renal Function Among Haemodialysis Patients Receiving Irbesartan - a Double Blind Randomised Study |
| Study Start Date : | April 2009 |
| Actual Primary Completion Date : | January 2013 |
| Actual Study Completion Date : | January 2013 |
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: Irbesartan |
Drug: Irbesartan
Tablets, 300 mg * 1 daily, 1 year
Other Names:
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| Placebo Comparator: Placebo |
Drug: Placebo matching irbesartan 150 mg
Tablets, 300 mg * 1 daily, 1 year |
- Decrease in loss of residual kidney function. [ Time Frame: 3, 6, 9 and 12 months ]
- 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 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00791830
| Denmark | |
| Department of Nephrology, Aarhus University, Aalborg | |
| Aalborg, Denmark, 9000 | |
| Department of Nephrology, Aarhus University Hospital, Skejby | |
| Aarhus N, Denmark, 8200 | |
| Department of Medicine, Fredericia Hospital | |
| Fredericia, Denmark, 7000 | |
| Haemodialysis unit, Horsens Hospital | |
| Horsens, Denmark, 8700 | |
| Hemodialysis Unit, Randers Hospital | |
| Randers, Denmark, 8600 | |
| Department of Medicine M, Viborg Hospital | |
| Viborg, Denmark, 8800 | |
| 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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of Aarhus |
| ClinicalTrials.gov Identifier: | NCT00791830 History of Changes |
| Other Study ID Numbers: |
EudraCT no: 2008-001267-11 |
| First Posted: | November 17, 2008 Key Record Dates |
| Last Update Posted: | January 8, 2013 |
| Last Verified: | January 2013 |
Keywords provided by University of Aarhus:
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Residual renal function Haemodialysis Applanation tonometry |
Cardiac output Quality of life Angiotensin II Type 1 Receptor Blockers |
Additional relevant MeSH terms:
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Renal Insufficiency Kidney Failure, Chronic Kidney Diseases Urologic Diseases Renal Insufficiency, Chronic |
Irbesartan Angiotensin II Type 1 Receptor Blockers Antihypertensive Agents Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action |