A Phase 3 interventional study of Irbesartan and Placebo matching irbesartan 150 mg in Kidney Failure, Chronic, sponsored by University of Aarhus. Completed at 6 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-01-08.
Sponsored by University of Aarhus · Phase 3, Interventional, and Prevention
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.
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:
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.
1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.
This study's enrollment of 82 is above the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.
Browse Renal Insufficiency studies →University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.
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Exclusion Criteria:
Drug: Irbesartan
Drug: Placebo matching irbesartan 150 mg
Tablets, 300 mg \* 1 daily, 1 year
Also known as: Aprovel, Karvea, Avapro, CAS no: 138402-11-6, ATC code: C09CA04, PubChem: 3749, Drugbank: APRD00413
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
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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University of Aarhus