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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01100203
Recruitment Status : Terminated (It was not possible within the time frame to recruit the planned no. of patients.)
First Posted : April 8, 2010
Last Update Posted : February 8, 2012
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Lene Boesby, Herlev Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: Eplerenone Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
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
Study Start Date : April 2010
Actual Primary Completion Date : January 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Active Comparator: Treatment Drug: Eplerenone
25 mg once daily 1 week, then 50 mg once daily for another 23 weeks.

No Intervention: Control

Primary Outcome Measures :
  1. Pulse wave velocity [ Time Frame: 24 weeks ]
    Pulse wave velocity measured using the SphygmoCor device.

  2. Pulse Wave velocity [ Time Frame: 12 weeks ]
  3. Pulse wave velocity [ Time Frame: baseline ]

Secondary Outcome Measures :
  1. 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.

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

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

  4. Pulse wave analysis [ Time Frame: baseline ]
  5. Ambulatory arterial stiffness index [ Time Frame: baseline ]
  6. Ambulatory arterial stiffness index [ Time Frame: 12 weeks ]
  7. Pulse wave analysis [ Time Frame: 12 weeks ]
  8. Albuminuria [ Time Frame: 12 weeks ]
  9. Albuminuria [ Time Frame: 24 weeks ]
  10. 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.

  11. Estimated glomerular filtration rate (eGFR) [ Time Frame: 12 weeks ]
  12. Estimated glomerular filtration rate (eGFR) [ Time Frame: 24 weeks ]
  13. Plasma potassium [ Time Frame: baseline ]
  14. Plasma potassium [ Time Frame: week 1 ]
  15. Plasma potassium [ Time Frame: week 2 ]
  16. Plasma potassium [ Time Frame: week 4 ]
  17. Plasma potassium [ Time Frame: week 8 ]
  18. Plasma potassium [ Time Frame: week 12 ]
  19. Plasma potassium [ Time Frame: week 16 ]
  20. plasma potassium [ Time Frame: week 20 ]
  21. plasma potassium [ Time Frame: week 24 ]
  22. Blood pressure [ Time Frame: baseline ]
    BP will be measured at all visits

  23. Blood pressure [ Time Frame: 12 weeks ]
  24. Blood pressure [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01100203

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Dept. Nephrology, Herlev Hospital
Herlev, Denmark, DK-2730
Herlev Hospital
Herlev, Denmark, DK-2730
Sponsors and Collaborators
Lene Boesby
Rigshospitalet, Denmark
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Principal Investigator: Lene Boesby, MD Herlev Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Lene Boesby, MD, Herlev Hospital Identifier: NCT01100203    
Other Study ID Numbers: ALBLOCK-2
First Posted: April 8, 2010    Key Record Dates
Last Update Posted: February 8, 2012
Last Verified: February 2012
Keywords provided by Lene Boesby, Herlev Hospital:
aldosterone receptor inhibition
arterial stiffness
ambulatory arterial stiffness index
Additional relevant MeSH terms:
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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
Antihypertensive Agents