Saving Residual Renal Function Among Haemodialysis Patients Receiving Irbesartan (SAFIR)

January 7, 2013 updated by: University of Aarhus

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • Department of Nephrology, Aarhus University, Aalborg
      • Aarhus N, Denmark, 8200
        • Department of Nephrology, Aarhus University Hospital, Skejby
      • Fredericia, Denmark, 7000
        • Department of Medicine, Fredericia Hospital
      • Horsens, Denmark, 8700
        • Haemodialysis unit, Horsens Hospital
      • Randers, Denmark, 8600
        • Hemodialysis Unit, Randers Hospital
      • Viborg, Denmark, 8800
        • Department of Medicine M, Viborg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo matching irbesartan 150 mg
Tablets, 300 mg * 1 daily, 1 year
Active Comparator: Irbesartan
Drug: Irbesartan
Tablets, 300 mg * 1 daily, 1 year
Other Names:
  • Aprovel
  • Avapro
  • Karvea
  • CAS no: 138402-11-6
  • ATC code: C09CA04
  • PubChem: 3749
  • Drugbank: APRD00413

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Decrease in loss of residual kidney function.
Time Frame: 3, 6, 9 and 12 months
3, 6, 9 and 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Cardio-vascular outcome assessed by applanation tonometry, echocardiography, Transonic measurements of cardiac output and markers in blood.
Time Frame: 1 year
1 year
Progression to anuria
Time Frame: 3, 6, 9 and 12 months
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Study Chair: Bente Jespersen, MD, DrMedSc, Department of Nephrology, Aarhus University Hospital, Skejby, Denmark
  • Study Chair: Erik Sloth, MD, DrMedSc, Department of Anaesthesiology and Intensive Care, Aarhus University Hospital, Skejby, Denmark
  • Study Chair: Jens Kristian D Jensen, MD, PhD, Department of Nephrology, Aarhus University Hospital, Skejby, Denmark
  • Study Director: Krista D Kjærgaard, MD, PhD, Department of Nephrology, Aarhus University Hospital, Skejby, Denmark
  • Study Chair: Christian D Peters, MD, Department of Nephrology, Aarhus University Hospital, Skejby, Denmark
  • Principal Investigator: Charlotte Strandhave, MD, Department of Nephrology, Aalborg University Hospital, Denmark
  • Principal Investigator: Ida N Tietze, MD, PhD, Department of Internal Medicine, Region Hospital Viborg, Denmark
  • Principal Investigator: Marija K Novosel, MD, Department of Internal Medicine, Region Hospital Fredericia, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

November 14, 2008

First Submitted That Met QC Criteria

November 14, 2008

First Posted (Estimate)

November 17, 2008

Study Record Updates

Last Update Posted (Estimate)

January 8, 2013

Last Update Submitted That Met QC Criteria

January 7, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EudraCT no: 2008-001267-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Kidney Failure, Chronic

Clinical Trials on Irbesartan

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Czech Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe