Chronic Kidney DiseaseIRAB2NCT01805362
RAS Blockade at Bedtime Versus on Awakening for Aldosterone Breakthrough
A study testing Randomization that determine the time of treatment in people with Chronic Kidney Disease, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Objective: To show that the frequency of aldosterone breakthrough is lower when RAS blockers are given at bedtime compared to on awaking, and to analyze the determinants and consequences of aldosterone breakthrough. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Randomization that determine the time of treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteFrance
- Study dates
- 27 Feb 2013to 12 Jan 2018
- Phase
- Interventional
- 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
- Chronic kidney disease stage 3 to 4,
- ACEI (captopril, enalapril, or ramipril), and/or ARB (losartan, valsartan, or irbesartan) on awaking for at least three months,
- History of hypertension or proteinuria > 0,5 g/24h or g/g creatininuria,
- Adult with social security insurance,
- Informed consent signed.
Who cannot join
- Office blood pressure ≥ 160/100 mmHg,
- Pathology with life expectancy < 1 year,
- Anti-aldosterone (spironolactone, eplerenone) or potassium sparing diuretics (modamide, amiloride), or direct renin inhibitor.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RAS Blockade at Bedtime Versus on Awakening for the Prevention of Aldosterone Breakthrough
Objective:
To show that the frequency of aldosterone breakthrough is lower when RAS blockers are given at bedtime compared to on awaking, and to analyze the determinants and consequences of aldosterone breakthrough.
Read more
Duration of the study: Inclusion 2 years, follow-up one year, total 3 years Design: prospective, multicenter, randomized, controlled, open label, two parallel groups.
Main selection criteria:
Inclusion criteria
- Chronic kidney disease stage 3 to 4,
- ACEI (captopril, enalapril, or ramipril), and/or ARB (losartan, valsartan, or irbesartan) on awaking for at least three months,
- History of hypertension or proteinuria > 0,5 g/24h or g/g créatininurie.
Exclusion criteria
- Office blood pressure ≥ 160/100 mmHg,
- Anti-aldosterone (spironolactone, eplerenone) or potassium sparing diuretics (modamide, amiloride), or direct renin inhibitor.
Evaluation criteria:
Primary: Serum aldosterone levels at one year.
Secondary:
- Serum aldosterone/renin ratio,
- 24h urine aldosterone,
- Significant aldosterone breakthrough defined by a >10% increase of serum aldosterone levels over baseline values,
- Aldosterone breakthrough defined by an increase of serum aldosterone levels over baseline values,
- HbA1c,
- Urinary albumin/creatinine ratio (UACR) on spot morning urine samples,
- Systolic home blood pressure (SBP),
- Estimated glomerular filtration rate (eGFR) using the MDRD equation.
Read the detailed description
Rational:
Serum aldosterone levels may increase despite blockade of the renin angiotensin system (RAS) with angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB). This aldosterone breakthrough might be associated with bad outcomes: left ventricular hypertrophy, proteinuria and progression of renal failure. Antihypertensive drugs are given either on awaking or at bedtime. RAS is stimulated during nighttime. RAS blockers and diuretics given on awaking may stimulate aldosterone synthesis, and favor aldosterone breakthrough.
Objective:
To show that the frequency of aldosterone breakthrough is lower when RAS blockers are given at bedtime compared to on awaking, and to analyze the determinants and consequences of aldosterone breakthrough.
Duration of the study: Inclusion 2 years, follow-up one year, total 3 years
Design: prospective, multicenter, randomized, controlled, open label, two parallel groups.
- Conditions
- Chronic Kidney Disease
- Being tested
- Randomization that determine the time of treatment
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Randomization that determine the time of treatmentOther
Also called Randomization determine if the treatment will be taken in the morning or in the evening without changing the treatment
| Study group | Role | What they receive |
|---|---|---|
| MORNING | Active comparator | patients continue to take their treatments (RAS blockers and diuretics) on awaking Receives: Other: Randomization that determine the time of treatment |
| EVENING | Experimental | Patients take their treatments(RAS blockers and diurectics)at bedtime Receives: Other: Randomization that determine the time of treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum aldosterone levels at one year
Measured: Level change between baseline and one year
Secondary outcomes (2)
Serum aldosterone/renin ratio
Measured: level change between baseline and 12 months
Significant aldosterone breakthrough Significant aldosterone breakthrough
Significant aldosterone breakthrough defined by a >10% increase of serum aldosterone levels over baseline values,
Measured: changes between baseline and one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2013 (estimated)
- Study start27 Feb 2013
- Primary completion24 Apr 2014
- Study completion12 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent ESNAULT, MD, Principal investigator, Nice University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01805362
- Sponsor's protocol ID
- 08-API-03
- Acronym
- IRAB2
- Status last verified
- Apr 2024
- First submitted
- 28 Feb 2013
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RAS Blockade at Bedtime Versus on Awakening for the Prevention of Aldosterone Breakthrough
- ClinicalTrials.gov ID
- NCT01805362
- Acronym / sponsor ID
- IRAB2 / 08-API-03
- Conditions
- Chronic Kidney Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 27 Feb 2013 (actual)
- Primary completion
- 24 Apr 2014 (actual)
- Study completion
- 12 Jan 2018 (actual)
- First posted
- 6 Mar 2013 (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.
Objective:
To show that the frequency of aldosterone breakthrough is lower when RAS blockers are given at bedtime compared to on awaking, and to analyze the determinants and consequences of aldosterone breakthrough.
Duration of the study: Inclusion 2 years, follow-up one year, total 3 years Design: prospective, multicenter, randomized, controlled, open label, two parallel groups.
Main selection criteria:
Inclusion criteria
- Chronic kidney disease stage 3 to 4,
- ACEI (captopril, enalapril, or ramipril), and/or ARB (losartan, valsartan, or irbesartan) on awaking for at least three months,
- History of hypertension or proteinuria > 0,5 g/24h or g/g créatininurie.
Exclusion criteria
- Office blood pressure ≥ 160/100 mmHg,
- Anti-aldosterone (spironolactone, eplerenone) or potassium sparing diuretics (modamide, amiloride), or direct renin inhibitor.
Evaluation criteria:
Primary: Serum aldosterone levels at one year.
Secondary:
- Serum aldosterone/renin ratio,
- 24h urine aldosterone,
- Significant aldosterone breakthrough defined by a >10% increase of serum aldosterone levels over baseline values,
- Aldosterone breakthrough defined by an increase of serum aldosterone levels over baseline values,
- HbA1c,
- Urinary albumin/creatinine ratio (UACR) on spot morning urine samples,
- Systolic home blood pressure (SBP),
- Estimated glomerular filtration rate (eGFR) using the MDRD equation.
Detailed description
Rational:
Serum aldosterone levels may increase despite blockade of the renin angiotensin system (RAS) with angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB). This aldosterone breakthrough might be associated with bad outcomes: left ventricular hypertrophy, proteinuria and progression of renal failure. Antihypertensive drugs are given either on awaking or at bedtime. RAS is stimulated during nighttime. RAS blockers and diuretics given on awaking may stimulate aldosterone synthesis, and favor aldosterone breakthrough.
Objective:
To show that the frequency of aldosterone breakthrough is lower when RAS blockers are given at bedtime compared to on awaking, and to analyze the determinants and consequences of aldosterone breakthrough.
Duration of the study: Inclusion 2 years, follow-up one year, total 3 years
Design: prospective, multicenter, randomized, controlled, open label, two parallel groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MORNING | Active comparator | Other: Randomization that determine the time of treatmentpatients continue to take their treatments (RAS blockers and diuretics) on awaking |
| EVENING | Experimental | Other: Randomization that determine the time of treatmentPatients take their treatments(RAS blockers and diurectics)at bedtime |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chronic kidney disease stage 3 to 4,
- ACEI (captopril, enalapril, or ramipril), and/or ARB (losartan, valsartan, or irbesartan) on awaking for at least three months,
- History of hypertension or proteinuria > 0,5 g/24h or g/g creatininuria,
- Adult with social security insurance,
- Informed consent signed.
Key exclusion criteria (3 listed)
- Office blood pressure ≥ 160/100 mmHg,
- Pathology with life expectancy < 1 year,
- Anti-aldosterone (spironolactone, eplerenone) or potassium sparing diuretics (modamide, amiloride), or direct renin inhibitor.
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 |
|---|---|---|
| Randomization that determine the time of treatmentAlso: Randomization determine if the treatment will be taken in the morning or in the evening without changing the treatment | Other | EVENING, MORNING |
Primary outcome
Serum aldosterone levels at one year
Time frame: Level change between baseline and one year
2 secondary outcomes
Serum aldosterone/renin ratio
Time frame: level change between baseline and 12 months
Significant aldosterone breakthrough Significant aldosterone breakthrough
Time frame: changes between baseline and one 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 11 Apr 2024.
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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.
Vincent ESNAULT, MD principal investigator
Nice University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Randomization that determine the time of treatment in people with Chronic Kidney Disease, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 5 inclusion and 3 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 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Serum aldosterone levels at one year (time frame: Level change between baseline and one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2024.