Skip to main content
OpenTrials
Completed

NCT Number: NCT00791830

Saving Residual Renal Function Among Haemodialysis Patients Receiving Irbesartan

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Nephrology, Aarhus University, Aalborg, Aalborg, Denmark

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Irbesartan

Drug

Tablets, 300 mg * 1 daily, 1 year

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

Placebo matching irbesartan 150 mg

Drug

Tablets, 300 mg * 1 daily, 1 year

Primary outcomes

  1. Decrease in loss of residual kidney function.

    Time frame: 3, 6, 9 and 12 months

Secondary outcomes

  1. Cardio-vascular outcome assessed by applanation tonometry, echocardiography, Transonic measurements of cardiac output and markers in blood.

    Time frame: 1 year

  2. Progression to anuria

    Time frame: 3, 6, 9 and 12 months

  3. Quality of life assessed by a questionnaire: Kidney Disease Quality Of Life - Short Form (KDQOL-SF)

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Acronym: SAFIR

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Nov 17, 2008
Registry last updated
Jan 8, 2013

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.