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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.)
Sponsor:
Collaborator:
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Lene Boesby, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT01100203
First received: April 6, 2010
Last updated: February 7, 2012
Last verified: February 2012
History of Changes
  Purpose

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: 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:

Drug Information available for: Eplerenone
U.S. FDA Resources

Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • Pulse wave velocity [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Pulse wave velocity measured using the SphygmoCor device.

  • Pulse Wave velocity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Pulse wave velocity [ Time Frame: baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ambulatory arterial stiffness index [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Parameters are Augmentation Index, subendocardial viability ratio, pulse, time to reflection, ejection duration.

  • Albuminuria [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Will be calculated from 24 hour urine collections.

  • Pulse wave analysis [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Ambulatory arterial stiffness index [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Ambulatory arterial stiffness index [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Pulse wave analysis [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Albuminuria [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Albuminuria [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Estimated glomerular filtration rate (eGFR) [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • Estimated glomerular filtration rate (eGFR) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Plasma potassium [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
  • Plasma potassium [ Time Frame: week 1 ] [ Designated as safety issue: Yes ]
  • Plasma potassium [ Time Frame: week 2 ] [ Designated as safety issue: Yes ]
  • Plasma potassium [ Time Frame: week 4 ] [ Designated as safety issue: Yes ]
  • Plasma potassium [ Time Frame: week 8 ] [ Designated as safety issue: Yes ]
  • Plasma potassium [ Time Frame: week 12 ] [ Designated as safety issue: Yes ]
  • Plasma potassium [ Time Frame: week 16 ] [ Designated as safety issue: Yes ]
  • plasma potassium [ Time Frame: week 20 ] [ Designated as safety issue: Yes ]
  • plasma potassium [ Time Frame: week 24 ] [ Designated as safety issue: Yes ]
  • Blood pressure [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
    BP will be measured at all visits

  • Blood pressure [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Blood pressure [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01100203

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

No publications provided

Responsible Party: Lene Boesby, MD, Herlev Hospital
ClinicalTrials.gov Identifier: NCT01100203     History of Changes
Other Study ID Numbers: ALBLOCK-2
Study First Received: April 6, 2010
Last Updated: February 7, 2012
Health Authority: United States: Food and Drug Administration
Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: Ethics Committee

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

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency
Eplerenone
 Aldosterone Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013