TerminatedNCT01100203ALBLOCK-2Updated Feb 8, 2012

Aldosterone Blockade in Chronic Kidney Disease: Influence on Arterial Stiffness and Kidney Function

A Phase 3 interventional study of Eplerenone in Chronic Kidney Disease, sponsored by Lene Boesby. Terminated at 2 sites in Denmark. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-02-08.

Sponsored by Lene Boesby · Phase 3, Interventional, and Treatment

Why this study was terminated

It was not possible within the time frame to recruit the planned no. of patients.

Phase: Phase 3
Study type: Interventional
Enrollment: 54
Allocation: Randomized
Ages: 18 Years to 80 Years
Sex: All

Study 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. 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 studied

Chronic Kidney Disease

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Keywords

aldosterone receptor inhibition
arterial stiffness
ambulatory arterial stiffness index

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 54 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Lene Boesby is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

≥ 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

Exclusion criteria

Exclusion Criteria:

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)
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

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 54 participants (actual)

Study arms

Active comparator
Treatment
Drug: Eplerenone
No intervention
Control

Interventions

DrugEplerenone
25 mg once daily 1 week, then 50 mg once daily for another 23 weeks.

What researchers measure

Primary outcomes

Pulse wave velocity
Pulse wave velocity measured using the SphygmoCor device.
Time frame: 24 weeks
Pulse Wave velocity
Time frame: 12 weeks
Pulse wave velocity
Time frame: baseline

Secondary outcomes

Ambulatory arterial stiffness index
24 hour ambulatory blood pressure measurements, give rise to the index, which is a secondary measure of arterial compliance.
Time frame: 24 weeks
Pulse wave analysis
Parameters are Augmentation Index, subendocardial viability ratio, pulse, time to reflection, ejection duration.
Time frame: 24 weeks
Albuminuria
Will be calculated from 24 hour urine collections.
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)
Estimated glomerular filtration rate (eGFR) will be calculated by using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
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
BP will be measured at all visits
Time frame: baseline
Blood pressure
Time frame: 12 weeks
Blood pressure
Time frame: 24 weeks

Study locations

2 sites

Dept. Nephrology, Herlev Hospital
Herlev, DK-2730, Denmark
Herlev Hospital
Herlev, DK-2730, Denmark

References and documents

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 33107592 ↗
Boesby 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 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 8, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01100203
Lead sponsor: Lene Boesby
Collaborators: Rigshospitalet, Denmark
Responsible party: Lene Boesby (MD, Herlev Hospital) — Sponsor-investigator
First posted: Apr 8, 2010
Start date: Apr 2010
Primary completion: Jan 2012
Completion: Feb 2012
Last update: Feb 8, 2012

Study contacts

Lene Boesby, MD

principal investigator · Herlev Hospital

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

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