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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.
 
ClinicalTrials.gov 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
Sponsor:
Collaborator:
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Lene Boesby, Herlev Hospital

Tracking Information
First Submitted Date  ICMJE April 6, 2010
First Posted Date  ICMJE April 8, 2010
Last Update Posted Date February 8, 2012
Study Start Date  ICMJE April 2010
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 7, 2010)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2012)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 7, 2010)
  • 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 ]
  • Epidermal growth factor receptor (eGFR) [ Time Frame: baseline ]
    eGFR will be calculated by using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
  • eGFR [ Time Frame: 12 weeks ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aldosterone Blockade in Chronic Kidney Disease: Influence on Arterial Stiffness and Kidney Function
Official Title  ICMJE Aldosterone Blockade in Chronic Kidney Disease. Influence on Arterial Stiffness and Kidney Function
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Kidney Disease
Intervention  ICMJE Drug: Eplerenone
25 mg once daily 1 week, then 50 mg once daily for another 23 weeks.
Study Arms  ICMJE
  • Active Comparator: Treatment
    Intervention: Drug: Eplerenone
  • No Intervention: Control
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 7, 2012)
54
Original Estimated Enrollment  ICMJE
 (submitted: April 7, 2010)
80
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01100203
Other Study ID Numbers  ICMJE ALBLOCK-2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lene Boesby, Herlev Hospital
Study Sponsor  ICMJE Lene Boesby
Collaborators  ICMJE Rigshospitalet, Denmark
Investigators  ICMJE
Principal Investigator: Lene Boesby, MD Herlev Hospital
PRS Account Herlev Hospital
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP