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

Chronic Kidney Disease Clinical Trial

— ALBLOCK-2  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01100203
• Other study ID #: ALBLOCK-2
• Status: Terminated
• Phase: Phase 3
• First received: April 6, 2010
• Last updated: February 7, 2012
• Start date: April 2010
• Est. completion date: February 2012

Study information

• Verified date: February 2012
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationDenmark: Danish Dataprotection AgencyDenmark: Danish Medicines AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 54
• Est. completion date: February 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Eplerenone
25 mg once daily 1 week, then 50 mg once daily for another 23 weeks.

Locations

Country	Name	City	State
Denmark	Dept. Nephrology, Herlev Hospital	Herlev
Denmark	Herlev Hospital	Herlev

Sponsors (2)

Lead Sponsor	Collaborator
Lene Boesby	Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulse wave velocity	Pulse wave velocity measured using the SphygmoCor device.	24 weeks	No
Primary	Pulse Wave velocity		12 weeks	No
Primary	Pulse wave velocity		baseline	No
Secondary	Ambulatory arterial stiffness index	24 hour ambulatory blood pressure measurements, give rise to the index, which is a secondary measure of arterial compliance.	24 weeks	No
Secondary	Pulse wave analysis	Parameters are Augmentation Index, subendocardial viability ratio, pulse, time to reflection, ejection duration.	24 weeks	No
Secondary	Albuminuria	Will be calculated from 24 hour urine collections.	baseline	No
Secondary	Pulse wave analysis		baseline	No
Secondary	Ambulatory arterial stiffness index		baseline	No
Secondary	Ambulatory arterial stiffness index		12 weeks	No
Secondary	Pulse wave analysis		12 weeks	No
Secondary	Albuminuria		12 weeks	No
Secondary	Albuminuria		24 weeks	No
Secondary	Estimated glomerular filtration rate (eGFR)	Estimated glomerular filtration rate (eGFR) will be calculated by using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.	baseline	Yes
Secondary	Estimated glomerular filtration rate (eGFR)		12 weeks	Yes
Secondary	Estimated glomerular filtration rate (eGFR)		24 weeks	Yes
Secondary	Plasma potassium		baseline	Yes
Secondary	Plasma potassium		week 1	Yes
Secondary	Plasma potassium		week 2	Yes
Secondary	Plasma potassium		week 4	Yes
Secondary	Plasma potassium		week 8	Yes
Secondary	Plasma potassium		week 12	Yes
Secondary	Plasma potassium		week 16	Yes
Secondary	plasma potassium		week 20	Yes
Secondary	plasma potassium		week 24	Yes
Secondary	Blood pressure	BP will be measured at all visits	baseline	Yes
Secondary	Blood pressure		12 weeks	Yes
Secondary	Blood pressure		24 weeks	Yes