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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-02-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Group Type ACTIVE_COMPARATOR

Eplerenone

Intervention Type DRUG

25 mg once daily 1 week, then 50 mg once daily for another 23 weeks.

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Eplerenone

25 mg once daily 1 week, then 50 mg once daily for another 23 weeks.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No