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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00791830
First received: November 14, 2008
Last updated: January 7, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Kidney Failure, Chronic
Drug: Irbesartan
Drug: Placebo matching irbesartan 150 mg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Saving Residual Renal Function Among Haemodialysis Patients Receiving Irbesartan - a Double Blind Randomised Study

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Decrease in loss of residual kidney function. [ Time Frame: 3, 6, 9 and 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Cardio-vascular outcome assessed by applanation tonometry, echocardiography, Transonic measurements of cardiac output and markers in blood. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Progression to anuria [ Time Frame: 3, 6, 9 and 12 months ] [ Designated as safety issue: Yes ]
  • Quality of life assessed by a questionnaire: Kidney Disease Quality Of Life - Short Form (KDQOL-SF) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 82
Study Start Date: April 2009
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Irbesartan Drug: Irbesartan
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 Comparator: Placebo Drug: Placebo matching irbesartan 150 mg
Tablets, 300 mg * 1 daily, 1 year

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00791830

Locations
Denmark
Department of Nephrology, Aarhus University, Aalborg
Aalborg, Denmark, 9000
Department of Nephrology, Aarhus University Hospital, Skejby
Aarhus N, Denmark, 8200
Department of Medicine, Fredericia Hospital
Fredericia, Denmark, 7000
Haemodialysis unit, Horsens Hospital
Horsens, Denmark, 8700
Hemodialysis Unit, Randers Hospital
Randers, Denmark, 8600
Department of Medicine M, Viborg Hospital
Viborg, Denmark, 8800
Sponsors and Collaborators
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
  More Information

No publications provided by University of Aarhus

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT00791830     History of Changes
Other Study ID Numbers: EudraCT no: 2008-001267-11
Study First Received: November 14, 2008
Last Updated: January 7, 2013
Health Authority: Denmark: Danish Medicines Agency
Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:
Residual renal function
Haemodialysis
Applanation tonometry
Cardiac output
Quality of life
Angiotensin II Type 1 Receptor Blockers

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Angiotensin II Type 1 Receptor Blockers
Irbesartan
Angiotensin Receptor Antagonists
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014