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| Sponsored by: |
University of Aarhus |
|---|---|
| Information provided by: | University of Aarhus |
| ClinicalTrials.gov Identifier: | NCT00791830 |
Purpose
Angiontensin 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 adressed.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Failure, Chronic |
Drug: Irbesartan Drug: Placebo matching irbesartan 150 mg |
Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Saving Residual Renal Function Among Haemodialysis Patients Receiving Irbesartan - a Double Blind Randomised Study |
| Estimated Enrollment: | 80 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Irbesartan: Active Comparator |
Drug: Irbesartan
Tablets, 300 mg * 1 daily, 1 year
|
| Placebo: Placebo Comparator |
Drug: Placebo matching irbesartan 150 mg
Tablets, 300 mg * 1 daily, 1 year
|
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 - adressed 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 (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, GFR and urine volume will be determined after 3, 6, 9 and 12 months giving a regression line for each patient. 6 dialysis units will be recruiting patients.
Investigations:
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 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Krista D Kjærgaard, MD | +45 22 32 43 21 | krista@ki.au.dk |
| Contact: Jens Kristian D Jensen, MD, PhD | + 45 89 49 57 77 | jensdam@dadlnet.dk |
| Denmark | |
| Department of Nephrology, Aarhus University Hospital, Skejby | |
| Aarhus N, Denmark, 8200 | |
| Haemodialysis unit, Randers Hospital | |
| Randers, Denmark, 8900 | |
| Haemodialysis unit, Horsens Hospital | |
| Horsens, Denmark, 8700 | |
| Department of Medicine M, Viborg Hospital | |
| Viborg, Denmark, 8800 | |
| Department of Nephrology, Aarhus University, Aalborg | |
| Aalborg, Denmark, 9000 | |
| Department of Medicine, Fredericia Hospital | |
| Fredericia, Denmark, 7000 | |
| Study Director: | Bente Jespersen, MD, DMSci | Department of Nephrology, Aarhus University Hospital, Skejby, Denmark |
| Study Chair: | Erik Sloth, MD, DMSci | Department of Anaesthesiology and Intensive Care, Aarhus University Hospital, Skejby, Denmark |
| Study Director: | Jens Kristian D Jensen, MD, PhD | Department of Nephrology, Aarhus University Hospital, Skejby, Denmark |
| Principal Investigator: | Krista D Kjærgaard, MD | Department of Nephrology, Aarhus University Hospital, Skejby, Denmark |
More Information
| Responsible Party: | Aarhus University Hospital, Skejby ( Krista Dybtved Kjærgaard, MD ) |
| Study ID Numbers: | EudraCT no: 2008-001267-11 |
| Study First Received: | November 14, 2008 |
| Last Updated: | November 14, 2008 |
| ClinicalTrials.gov Identifier: | NCT00791830 |
| Health Authority: | Denmark: Danish Medicines Agency; Denmark: Ethics Committee; Denmark: Danish Dataprotection Agency; Denmark: GCP (Good Clinical Practice) units in Aarhus and Odense |
|
Residual renal function Haemodialysis Applanation tonometry |
Cardiac output Quality of life Angiotensin II Type 1 Receptor Blockers |
|
Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic Irbesartan Kidney Failure, Chronic |
Quality of Life Kidney Diseases Angiotensin II Kidney Failure |
|
Angiotensin II Type 1 Receptor Blockers Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |
