Saving Residual Renal Function Among Haemodialysis Patients Receiving Irbesartan

Kidney Failure, Chronic Clinical Trial

— SAFIR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00791830
• Other study ID #: EudraCT no: 2008-001267-11
• Status: Completed
• Phase: Phase 3
• First received: November 14, 2008
• Last updated: January 7, 2013
• Start date: April 2009
• Est. completion date: January 2013

Study information

• Verified date: January 2013
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Drug:
• Irbesartan
Tablets, 300 mg * 1 daily, 1 year
• Placebo matching irbesartan 150 mg
Tablets, 300 mg * 1 daily, 1 year

Locations

Country	Name	City	State
Denmark	Department of Nephrology, Aarhus University, Aalborg	Aalborg
Denmark	Department of Nephrology, Aarhus University Hospital, Skejby	Aarhus N
Denmark	Department of Medicine, Fredericia Hospital	Fredericia
Denmark	Haemodialysis unit, Horsens Hospital	Horsens
Denmark	Hemodialysis Unit, Randers Hospital	Randers
Denmark	Department of Medicine M, Viborg Hospital	Viborg

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in loss of residual kidney function.		3, 6, 9 and 12 months	Yes
Secondary	Cardio-vascular outcome assessed by applanation tonometry, echocardiography, Transonic measurements of cardiac output and markers in blood.		1 year	Yes
Secondary	Progression to anuria		3, 6, 9 and 12 months	Yes
Secondary	Quality of life assessed by a questionnaire: Kidney Disease Quality Of Life - Short Form (KDQOL-SF)		1 year	No