Chronic Kidney DiseasePhase 3ALBLOCK-2NCT01100203
Aldosterone Blockade in Chronic Kidney Disease: Influence on Arterial Stiffness and Kidney Function
A Phase 3 study testing Eplerenone in people with Chronic Kidney Disease, run by Lene Boesby at 2 sites in Denmark.
Trial summary
Patients with Chronic Kidney Disease (CKD) have a poor prognosis primarily due to cardiovascular disease. The cardiovascular risk can be assessed by measurements of arterial stiffness. A decrease in stiffness has been shown to decrease the risk of cardiovascular disease as well as death. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Eplerenone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesDenmark
- Study dates
- Apr 2010to Feb 2012
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years age ≤ 80 years age
- voluntarily signed informed consent
- 15 ml/min/1,73 m2 ≤ estimated Glomerular Filtration Rate < 60 ml/min/1,73 m2
- BP ≥ 130/80 mmHg or undergoing anti-hypertensive treatment
Who cannot join
- p-potassium is > 5.0 mM
- allergy to contents
- treated with spironolactone
- treated with potent inhibitors of CYP3A4 (see SPC for details)
- treated with lithium, ciclosporin, tacrolimus, prednisolone, or other immunosuppressing drug
- inborn errors of metabolism (see SPC for details)
Show all 13Show fewer
- pregnancy or lactation
- fertile woman, not using safe contraception devices
- dementia or other psychiatric disorder, making understanding of the study conditions impossible
- other severe, chronic illness besides CKD, including liver insufficiency, according to investigators' judgement
- vascular surgery including stenting or graft implantation on a. brachialis, aorta or the carotid arteries
- systolic BP > 200 mmHg
- immeasurable pulse amplitude
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Dept. Nephrology, Herlev Hospital
Herlev, DK-2730
Herlev Hospital
Herlev, DK-2730
About this study
Official title: Aldosterone Blockade in Chronic Kidney Disease. Influence on Arterial Stiffness and Kidney Function
Patients with Chronic Kidney Disease (CKD) have a poor prognosis primarily due to cardiovascular disease. The cardiovascular risk can be assessed by measurements of arterial stiffness. A decrease in stiffness has been shown to decrease the risk of cardiovascular disease as well as death. Most of the CKD population also have hypertension and the control of blood pressure is one of the corner stones in inhibition of disease progression. Using drugs that specifically block the renin-angiotensin-system for blood pressure control has been shown to have a beneficial impact on inhibition of progression beyond that of the achieved blood pressure control. It has been reported that inhibition of the hormone aldosterone has a positive effect on survival in patients with heart failure, hypertension and diabetic as well as on-diabetic nephropathy.
This study undertakes the investigation of the influence on arterial stiffness of adding an aldosterone receptor inhibitor to the medication CKD patients are already taking. Besides the primary end point which is Pulse wave velocity (PWV), arterial stiffness is also quantified thorough ambulatory blood pressure measurements.
- Conditions
- Chronic Kidney Disease
- Being tested
- Eplerenone
- Keywords
- aldosterone receptor inhibition, arterial stiffness, ambulatory arterial stiffness index
- 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.
EplerenoneDrug
25 mg once daily 1 week, then 50 mg once daily for another 23 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | Not described Receives: Drug: Eplerenone |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse wave velocity
Pulse wave velocity measured using the SphygmoCor device.
Measured: 24 weeks
Pulse Wave velocity
Measured: 12 weeks
Pulse wave velocity
Measured: baseline
Secondary outcomes (24)
Ambulatory arterial stiffness index
24 hour ambulatory blood pressure measurements, give rise to the index, which is a secondary measure of arterial compliance.
Measured: 24 weeks
Pulse wave analysis
Parameters are Augmentation Index, subendocardial viability ratio, pulse, time to reflection, ejection duration.
Measured: 24 weeks
Albuminuria
Will be calculated from 24 hour urine collections.
Measured: baseline
Pulse wave analysis
Measured: baseline
Ambulatory arterial stiffness index
Measured: baseline
Ambulatory arterial stiffness index
Measured: 12 weeks
Pulse wave analysis
Measured: 12 weeks
Albuminuria
Measured: 12 weeks
Albuminuria
Measured: 24 weeks
Estimated glomerular filtration rate (eGFR)
Estimated glomerular filtration rate (eGFR) will be calculated by using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
Measured: baseline
Estimated glomerular filtration rate (eGFR)
Measured: 12 weeks
Estimated glomerular filtration rate (eGFR)
Measured: 24 weeks
Plasma potassium
Measured: baseline
Plasma potassium
Measured: week 1
Plasma potassium
Measured: week 2
Plasma potassium
Measured: week 4
Plasma potassium
Measured: week 8
Plasma potassium
Measured: week 12
Plasma potassium
Measured: week 16
plasma potassium
Measured: week 20
plasma potassium
Measured: week 24
Blood pressure
BP will be measured at all visits
Measured: baseline
Blood pressure
Measured: 12 weeks
Blood pressure
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionJan 2012
- Study completionFeb 2012
Why it stopped: It was not possible within the time frame to recruit the planned no. of patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lene Boesby
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Sponsor-investigator, Lene Boesby, Herlev Hospital
- Investigators
- Lene Boesby, MD, Principal investigator, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01100203
- Sponsor's protocol ID
- ALBLOCK-2
- Acronym
- ALBLOCK-2
- Status last verified
- Feb 2012
- First submitted
- 6 Apr 2010
- Last updated
- 8 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10(10):CD007004. doi: 10.1002/14651858.CD007004.pub4.
PubMed 33107592Boesby L, Elung-Jensen T, Strandgaard S, Kamper AL. Eplerenone attenuates pulse wave reflection in chronic kidney disease stage 3-4--a randomized controlled study. PLoS One. 2013 May 21;8(5):e64549. doi: 10.1371/journal.pone.0064549. Print 2013.
PubMed 23704994
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aldosterone Blockade in Chronic Kidney Disease. Influence on Arterial Stiffness and Kidney Function
- ClinicalTrials.gov ID
- NCT01100203
- Acronym / sponsor ID
- ALBLOCK-2 / ALBLOCK-2
- Conditions
- Chronic Kidney Disease
- Keywords
- aldosterone receptor inhibition, arterial stiffness, ambulatory arterial stiffness index
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: It was not possible within the time frame to recruit the planned no. of patients.
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Lene BoesbyUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- Apr 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 8 Apr 2010 (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.
Patients with Chronic Kidney Disease (CKD) have a poor prognosis primarily due to cardiovascular disease. The cardiovascular risk can be assessed by measurements of arterial stiffness. A decrease in stiffness has been shown to decrease the risk of cardiovascular disease as well as death. Most of the CKD population also have hypertension and the control of blood pressure is one of the corner stones in inhibition of disease progression. Using drugs that specifically block the renin-angiotensin-system for blood pressure control has been shown to have a beneficial impact on inhibition of progression beyond that of the achieved blood pressure control. It has been reported that inhibition of the hormone aldosterone has a positive effect on survival in patients with heart failure, hypertension and diabetic as well as on-diabetic nephropathy.
This study undertakes the investigation of the influence on arterial stiffness of adding an aldosterone receptor inhibitor to the medication CKD patients are already taking. Besides the primary end point which is Pulse wave velocity (PWV), arterial stiffness is also quantified thorough ambulatory blood pressure measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Drug: Eplerenone |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 18 years age ≤ 80 years age
- voluntarily signed informed consent
- 15 ml/min/1,73 m2 ≤ estimated Glomerular Filtration Rate < 60 ml/min/1,73 m2
- BP ≥ 130/80 mmHg or undergoing anti-hypertensive treatment
Key exclusion criteria (13 listed)
- p-potassium is > 5.0 mM
- allergy to contents
- treated with spironolactone
- treated with potent inhibitors of CYP3A4 (see SPC for details)
- treated with lithium, ciclosporin, tacrolimus, prednisolone, or other immunosuppressing drug
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 |
|---|---|---|
| Eplerenone25 mg once daily 1 week, then 50 mg once daily for another 23 weeks. | Drug | Treatment |
Primary outcome
Pulse wave velocity
Time frame: 24 weeks
Pulse wave velocity measured using the SphygmoCor device.
Pulse Wave velocity
Time frame: 12 weeks
Pulse wave velocity
Time frame: baseline
24 secondary outcomes
Ambulatory arterial stiffness index
Time frame: 24 weeks
Pulse wave analysis
Time frame: 24 weeks
Albuminuria
Time frame: baseline
Pulse wave analysis
Time frame: baseline
Ambulatory arterial stiffness index
Time frame: baseline
Ambulatory arterial stiffness index
Time frame: 12 weeks
Pulse wave analysis
Time frame: 12 weeks
Albuminuria
Time frame: 12 weeks
Albuminuria
Time frame: 24 weeks
Estimated glomerular filtration rate (eGFR)
Time frame: baseline
Estimated glomerular filtration rate (eGFR)
Time frame: 12 weeks
Estimated glomerular filtration rate (eGFR)
Time frame: 24 weeks
Plasma potassium
Time frame: baseline
Plasma potassium
Time frame: week 1
Plasma potassium
Time frame: week 2
Plasma potassium
Time frame: week 4
Plasma potassium
Time frame: week 8
Plasma potassium
Time frame: week 12
Plasma potassium
Time frame: week 16
plasma potassium
Time frame: week 20
plasma potassium
Time frame: week 24
Blood pressure
Time frame: baseline
Blood pressure
Time frame: 12 weeks
Blood pressure
Time frame: 24 weeks
Results and safety
The study was stopped early (reason given: It was not possible within the time frame to recruit the planned no. of patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2012.
- Derived from this study: PubMed 33107592Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10(10):CD007004. doi: 10.1002/14651858.CD007004.pub4.
- Derived from this study: PubMed 23704994Boesby L, Elung-Jensen T, Strandgaard S, Kamper AL. Eplerenone attenuates pulse wave reflection in chronic kidney disease stage 3-4--a randomized controlled study. PLoS One. 2013 May 21;8(5):e64549. doi: 10.1371/journal.pone.0064549. Print 2013.
Related trials for Chronic Kidney Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
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.
Lene Boesby, MD principal investigator
Herlev Hospital
2 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 Eplerenone in people with Chronic Kidney Disease, run by Lene Boesby at 2 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 4 inclusion and 13 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: stopped early, as of the sponsor's last update on 8 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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 was stopped early (reason given: It was not possible within the time frame to recruit the planned no. of patients.). Results are not available in the source record.
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?
Pulse wave velocity (time frame: 24 weeks). The study lists 3 primary outcomes in all. 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 NCT01100203, which also lists 2 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 Feb 2012.