Kidney Failure, ChronicPhase 3SAFIRNCT00791830
Saving Residual Renal Function Among Haemodialysis Patients Receiving Irbesartan
A Phase 3 study testing Irbesartan in people with Kidney Failure, Chronic, run by University of Aarhus at 6 sites in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Chronic
- What is being tested?
- Irbesartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 6 sitesDenmark
- Study dates
- Apr 2009to Jan 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Haemodialysis patient
- Haemodialysis treatment for maximum 12 months
- > 18 years old
- informed consent
- urine volume > 300 ml / 24 hours
- contraception if fertile woman
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Denmark6 sites
Department of Nephrology, Aarhus University, Aalborg
Aalborg, 9000
Department of Nephrology, Aarhus University Hospital, Skejby
Aarhus N, 8200
Department of Medicine, Fredericia Hospital
Fredericia, 7000
Haemodialysis unit, Horsens Hospital
Horsens, 8700
Hemodialysis Unit, Randers Hospital
Randers, 8600
Department of Medicine M, Viborg Hospital
Viborg, 8800
About this study
Official title: 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.
Read the 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.
- Conditions
- Kidney Failure, Chronic
- Being tested
- Irbesartan, Placebo matching irbesartan 150 mg
- Keywords
- Residual renal function, Haemodialysis, Applanation tonometry, Cardiac output, Quality of life, Angiotensin II Type 1 Receptor Blockers
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrbesartanDrug
Also called Aprovel, Karvea, Avapro, CAS no: 138402-11-6
Tablets, 300 mg * 1 daily, 1 year
Placebo matching irbesartan 150 mgDrug
Tablets, 300 mg * 1 daily, 1 year
| Study group | Role | What they receive |
|---|---|---|
| Irbesartan | Active comparator | Not described Receives: Drug: Irbesartan |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo matching irbesartan 150 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in loss of residual kidney function.
Measured: 3, 6, 9 and 12 months
Secondary outcomes (3)
Cardio-vascular outcome assessed by applanation tonometry, echocardiography, Transonic measurements of cardiac output and markers in blood.
Measured: 1 year
Progression to anuria
Measured: 3, 6, 9 and 12 months
Quality of life assessed by a questionnaire: Kidney Disease Quality Of Life - Short Form (KDQOL-SF)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2008 (estimated)
- Study startApr 2009
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bente Jespersen, MD, DrMedSc, Study chair, Department of Nephrology, Aarhus University Hospital, Skejby, DenmarkErik Sloth, MD, DrMedSc, Study chair, Department of Anaesthesiology and Intensive Care, Aarhus University Hospital, Skejby, DenmarkJens Kristian D Jensen, MD, PhD, Study chair, Department of Nephrology, Aarhus University Hospital, Skejby, DenmarkKrista D Kjærgaard, MD, PhD, Study director, Department of Nephrology, Aarhus University Hospital, Skejby, DenmarkChristian D Peters, MD, Study chair, Department of Nephrology, Aarhus University Hospital, Skejby, DenmarkCharlotte Strandhave, MD, Principal investigator, Department of Nephrology, Aalborg University Hospital, DenmarkIda N Tietze, MD, PhD, Principal investigator, Department of Internal Medicine, Region Hospital Viborg, DenmarkMarija K Novosel, MD, Principal investigator, Department of Internal Medicine, Region Hospital Fredericia, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00791830
- Sponsor's protocol ID
- EudraCT no: 2008-001267-11
- Acronym
- SAFIR
- Status last verified
- Jan 2013
- First submitted
- 14 Nov 2008
- Last updated
- 8 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Peters CD, Kjaergaard KD, Christensen KL, Bibby BM, Jespersen B, Jensen JD. High-sensitivity Troponin T in hemodialysis patients: a randomized placebo-controlled sub-study investigating angiotensin-II-blockade, variation over time and associations with clinical outcome. BMC Nephrol. 2020 Oct 28;21(1):452. doi: 10.1186/s12882-020-02103-1.
PubMed 33115436Peters CD, Kjaergaard KD, Jensen JD, Christensen KL, Strandhave C, Tietze IN, Novosel MK, Bibby BM, Jespersen B. Short and Long-Term Effects of the Angiotensin II Receptor Blocker Irbesartan on Intradialytic Central Hemodynamics: A Randomized Double-Blind Placebo-Controlled One-Year Intervention Trial (the SAFIR Study). PLoS One. 2015 Jun 1;10(6):e0126882. doi: 10.1371/journal.pone.0126882. eCollection 2015.
PubMed 26030651Peters CD, Kjaergaard KD, Jespersen B, Christensen KL, Jensen JD. Renal and cardiovascular effects of irbesartan in dialysis patients--a randomized controlled trial protocol (SAFIR study). Dan Med J. 2013 Apr;60(4):A4602.
PubMed 23651713
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Saving Residual Renal Function Among Haemodialysis Patients Receiving Irbesartan - a Double Blind Randomised Study
- ClinicalTrials.gov ID
- NCT00791830
- Acronym / sponsor ID
- SAFIR / EudraCT no: 2008-001267-11
- Conditions
- Kidney Failure, Chronic
- Keywords
- Residual renal function, Haemodialysis, Applanation tonometry, Cardiac output, Quality of life, Angiotensin II Type 1 Receptor Blockers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 17 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Irbesartan | Active comparator | Drug: Irbesartan |
| Placebo | Placebo comparator | Drug: Placebo matching irbesartan 150 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Haemodialysis patient
- Haemodialysis treatment for maximum 12 months
- > 18 years old
- informed consent
- urine volume > 300 ml / 24 hours
Key exclusion criteria (6 listed)
- 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 %
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IrbesartanAlso: Aprovel, Karvea, Avapro, CAS no: 138402-11-6Tablets, 300 mg * 1 daily, 1 year | Drug | Irbesartan |
| Placebo matching irbesartan 150 mgTablets, 300 mg * 1 daily, 1 year | Drug | Placebo |
Primary outcome
Decrease in loss of residual kidney function.
Time frame: 3, 6, 9 and 12 months
3 secondary outcomes
Cardio-vascular outcome assessed by applanation tonometry, echocardiography, Transonic measurements of cardiac output and markers in blood.
Time frame: 1 year
Progression to anuria
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2013.
- Derived from this study: PubMed 33115436Peters CD, Kjaergaard KD, Christensen KL, Bibby BM, Jespersen B, Jensen JD. High-sensitivity Troponin T in hemodialysis patients: a randomized placebo-controlled sub-study investigating angiotensin-II-blockade, variation over time and associations with clinical outcome. BMC Nephrol. 2020 Oct 28;21(1):452. doi: 10.1186/s12882-020-02103-1.
- Derived from this study: PubMed 26030651Peters CD, Kjaergaard KD, Jensen JD, Christensen KL, Strandhave C, Tietze IN, Novosel MK, Bibby BM, Jespersen B. Short and Long-Term Effects of the Angiotensin II Receptor Blocker Irbesartan on Intradialytic Central Hemodynamics: A Randomized Double-Blind Placebo-Controlled One-Year Intervention Trial (the SAFIR Study). PLoS One. 2015 Jun 1;10(6):e0126882. doi: 10.1371/journal.pone.0126882. eCollection 2015.
- Derived from this study: PubMed 23651713Peters CD, Kjaergaard KD, Jespersen B, Christensen KL, Jensen JD. Renal and cardiovascular effects of irbesartan in dialysis patients--a randomized controlled trial protocol (SAFIR study). Dan Med J. 2013 Apr;60(4):A4602.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bente Jespersen, MD, DrMedSc study chair
Department of Nephrology, Aarhus University Hospital, Skejby, Denmark
Erik Sloth, MD, DrMedSc study chair
Department of Anaesthesiology and Intensive Care, Aarhus University Hospital, Skejby, Denmark
Jens Kristian D Jensen, MD, PhD study chair
Department of Nephrology, Aarhus University Hospital, Skejby, Denmark
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Irbesartan in people with Kidney Failure, Chronic, run by University of Aarhus at 6 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in loss of residual kidney function. (time frame: 3, 6, 9 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00791830, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2013.