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

Phase 3

Terminated

• Conditions: Chronic Kidney Disease
• Interventions: Drug: Eplerenone

• Registration Number: NCT01100203
• Lead Sponsor: Lene Boesby

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 available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-06
• Study First Submitted QC: 2010-04-07
• Study First Posted: 2010-04-08
• Primary Completion: 2012-01
• Status Verified: 2012-02
• Study Completion: 2012-02
• Last Update Submitted: 2012-02-07
• Last Update Posted: 2012-02-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 54

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Eplerenone	-

Primary Outcome Measures

Name	Time	Method
Pulse Wave velocity	12 weeks
Pulse wave velocity	baseline

Secondary Outcome Measures

Name	Time	Method
Ambulatory arterial stiffness index	12 weeks
Albuminuria	24 weeks
Estimated glomerular filtration rate (eGFR)	24 weeks
Plasma potassium	week 16
plasma potassium	week 24
Blood pressure	24 weeks
Pulse wave analysis	12 weeks

Trial Locations

Locations (2)

Dept. Nephrology, Herlev Hospital; 🇩🇰 Herlev, Denmark

Herlev Hospital; 🇩🇰 Herlev, Denmark