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Aldosterone Blockade in Chronic Kidney Disease: Influence on Arterial Stiffness and Kidney Function (ALBLOCK-2)

This study has been terminated.
(It was not possible within the time frame to recruit the planned no. of patients.)
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Lene Boesby, Herlev Hospital Identifier:
First received: April 6, 2010
Last updated: February 7, 2012
Last verified: February 2012

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.

Condition Intervention Phase
Chronic Kidney Disease Drug: Eplerenone Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Aldosterone Blockade in Chronic Kidney Disease. Influence on Arterial Stiffness and Kidney Function

Resource links provided by NLM:

Further study details as provided by Lene Boesby, Herlev Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Ambulatory arterial stiffness index [ Time Frame: 24 weeks ]
    24 hour ambulatory blood pressure measurements, give rise to the index, which is a secondary measure of arterial compliance.

  • Pulse wave analysis [ Time Frame: 24 weeks ]
    Parameters are Augmentation Index, subendocardial viability ratio, pulse, time to reflection, ejection duration.

  • Albuminuria [ Time Frame: baseline ]
    Will be calculated from 24 hour urine collections.

  • 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) will be calculated by using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.

  • 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 ]
    BP will be measured at all visits

  • Blood pressure [ Time Frame: 12 weeks ]
  • Blood pressure [ Time Frame: 24 weeks ]

Enrollment: 54
Study Start Date: April 2010
Study Completion Date: February 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment Drug: Eplerenone
25 mg once daily 1 week, then 50 mg once daily for another 23 weeks.
No Intervention: Control


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01100203

Dept. Nephrology, Herlev Hospital
Herlev, Denmark, DK-2730
Herlev Hospital
Herlev, Denmark, DK-2730
Sponsors and Collaborators
Lene Boesby
Rigshospitalet, Denmark
Principal Investigator: Lene Boesby, MD Herlev Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Lene Boesby, MD, Herlev Hospital Identifier: NCT01100203     History of Changes
Other Study ID Numbers: ALBLOCK-2
Study First Received: April 6, 2010
Last Updated: February 7, 2012

Keywords provided by Lene Boesby, Herlev Hospital:
aldosterone receptor inhibition
arterial stiffness
ambulatory arterial stiffness index

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Natriuretic Agents processed this record on August 17, 2017