Aldosterone Blockade in Chronic Kidney Disease: Influence... | NCT01100203

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

NCT01100203

Sponsor

Lene Boesby

Status

Terminated

Last Update Posted

Feb 8, 2012Estimated

Enrollment

54Actual

Phase

Phase 3

Conditions

Chronic Kidney Disease

Interventions

Eplerenone

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

It was not possible within the time frame to recruit the planned no. of patients.

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Jan 2012Actual

Completion Date

Feb 2012Actual

First Submitted Date

Apr 6, 2010

First Submission Date that Met QC Criteria

Apr 7, 2010

First Posted Date

Apr 8, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 7, 2012

Last Update Posted Date

Feb 8, 2012Estimated

Name	Class
Rigshospitalet, Denmark	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

54Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment	Active Comparator		Drug: Eplerenone
Control	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Eplerenone	Drug	25 mg once daily 1 week, then 50 mg once daily for another 23 weeks.	Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pulse wave velocity	Pulse wave velocity measured using the SphygmoCor device.	24 weeks
Pulse Wave velocity		12 weeks
Pulse wave velocity		baseline

Secondary Outcomes

Measure	Description	Time Frame
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
Pulse wave analysis

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lene Boesby, MD	Herlev Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. Nephrology, Herlev Hospital		Herlev		DK-2730	Denmark
Herlev Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33107592	Derived	Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10(10):CD007004. doi: 10.1002/14651858.CD007004.pub4.
23704994	Derived

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

ID	Term
D007783	Lactones
D009930	Organic Chemicals
D011283	Pregnenes
D011278	Pregnanes
D013256