Irbesartan
DrugTablets, 300 mg * 1 daily, 1 year
Other names: Aprovel, Karvea, Avapro, CAS no: 138402-11-6, ATC code: C09CA04, PubChem: 3749, Drugbank: APRD00413
NCT Number: NCT00791830
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 3
Department of Nephrology, Aarhus University, Aalborg, Aalborg, Denmark
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Tablets, 300 mg * 1 daily, 1 year
Other names: Aprovel, Karvea, Avapro, CAS no: 138402-11-6, ATC code: C09CA04, PubChem: 3749, Drugbank: APRD00413
Tablets, 300 mg * 1 daily, 1 year
Time frame: 3, 6, 9 and 12 months
Time frame: 1 year
Time frame: 3, 6, 9 and 12 months
Time frame: 1 year
University of Aarhus
Other
Saving Residual Renal Function Among Haemodialysis Patients Receiving Irbesartan - a Double Blind Randomised Study
Acronym: SAFIR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07716436
Behavior, Chronic Disease
Tanta, Gharbia Governorate, Egypt
View Trial DetailsNCT02910908
Chronic Disease, Disease Attributes
Nîmes, Gard, France
View Trial DetailsNCT04876963
Arrhythmias, Cardiac, Cardiovascular Diseases
Copenhagen, Denmark
View Trial DetailsNCT04466865
Behavior, Chronic Disease
Denver, Colorado, United States
View Trial Details