Trial | NCT00791830  Report issue

Title

Saving Residual Renal Function Among Haemodialysis Patients Receiving Irbesartan
Saving Residual Renal Function Among Haemodialysis Patients Receiving Irbesartan - a Double Blind Randomised Study

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    irbesartan ...

  • Study Participants

    82
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:

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 Started
Apr 30
2009
Primary Completion
Jan 31
2013
Study Completion
Jan 31
2013
Last Update
Jan 08
2013
Estimate

Drug Irbesartan

Tablets, 300 mg * 1 daily, 1 year

  • Other names: PubChem: 3749, Aprovel, Karvea, Avapro, CAS no: 138402-11-6, ATC code: C09CA04, Drugbank: APRD00413

Drug Placebo matching irbesartan 150 mg

Tablets, 300 mg * 1 daily, 1 year

Irbesartan Active Comparator

Placebo Placebo Comparator

Criteria 

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
No Results Posted