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Inhibition of Aldosterone in Patients With Chronic Renal Disease

Primary Purpose

Kidney Failure, Chronic

Status

Completed

Phase

Phase 4

Locations

Denmark

Study Type

Interventional

Intervention

Eplerenone

About this trial

This is an interventional prevention trial for Kidney Failure, Chronic focused on measuring Kidney Failure, Chronic, Proteinuria, Aldosterone, Renin-Angiotensin System

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Proteinuria > 500 mg/24 hours
Hypertension or anti-hypertensive treatment

Exclusion Criteria:

Diabetic nephropathy
GFR< 20 ml/min
P-potassium between 3,5 mmol/l and 5,0 mmol/l

Sites / Locations

Rigshospitalet, Blegdamsvej 9
Herlev Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Arm Description

Eplerenone

Control

Outcomes

Primary Outcome Measures

Proteinuria reduction

Secondary Outcome Measures

Evaluating blood pressure response and hyperkalaemia after aldosterone inhibition.

Full Information

NCT ID

NCT00430924

First Posted

February 1, 2007

Last Updated

February 7, 2012

Sponsor

Lene Boesby

Collaborators

Rigshospitalet, Denmark

1. Study Identification

Unique Protocol Identification Number

NCT00430924

Brief Title

Inhibition of Aldosterone in Patients With Chronic Renal Disease

Official Title

The Effect of Aldosterone Inhibition on Proteinuria in Patients With Progressive Renal Disease

Study Type

Interventional

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Completed

Study Start Date

March 2007 (undefined)

Primary Completion Date

August 2009 (Actual)

Study Completion Date

August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Lene Boesby

Collaborators

Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to examine whether the inhibition of aldosterone will result in lower excretion of protein via urine. The hypothesis is that if loss of protein is lowered, progression of renal disease with be slower than otherwise expected.

Detailed Description

Patients with chronic renal disease are likely to progress to end stage renal disease with the need for renal replacement therapy. It is accepted that proteinuria is a surrogate measurement for progression. If proteinuria can be lowered we hope to prolong patients pre-dialysis phase. Our theory is that aldosterone inhibition will lead to this. For a period of 8 weeks patients will be randomized to either aldosterone receptor inhibition with the drug eplerenone or control without. Blood pressures will be kept at the same level using other drugs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Failure, Chronic

Keywords

Kidney Failure, Chronic, Proteinuria, Aldosterone, Renin-Angiotensin System

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Eplerenone

Arm Title

Arm Type

No Intervention

Arm Description

Control

Intervention Type

Drug

Intervention Name(s)

Eplerenone

Intervention Description

Once daily administration for 8 weeks and 8 weeks control.

Primary Outcome Measure Information:

Title

Proteinuria reduction

Time Frame

bi-monthly

Secondary Outcome Measure Information:

Title

Evaluating blood pressure response and hyperkalaemia after aldosterone inhibition.

Time Frame

weekly

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Proteinuria > 500 mg/24 hours Hypertension or anti-hypertensive treatment Exclusion Criteria: Diabetic nephropathy GFR< 20 ml/min P-potassium between 3,5 mmol/l and 5,0 mmol/l

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Svend Strandgaard, DMSc

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Anne-Lise Kamper, DMSc

Organizational Affiliation

nonaffiliated

Official's Role

Study Director

Facility Information:

Facility Name

Rigshospitalet, Blegdamsvej 9

City

Copenhagen

ZIP/Postal Code

DK-2100 Ø

Country

Denmark

Facility Name

Herlev Hospital

City

Herlev

ZIP/Postal Code

DK-2730

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

33107592

Citation

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.

Results Reference

derived

PubMed Identifier

22073219

Citation

Boesby L, Elung-Jensen T, Klausen TW, Strandgaard S, Kamper AL. Moderate antiproteinuric effect of add-on aldosterone blockade with eplerenone in non-diabetic chronic kidney disease. A randomized cross-over study. PLoS One. 2011;6(11):e26904. doi: 10.1371/journal.pone.0026904. Epub 2011 Nov 4.

Results Reference

derived

Links:

URL

http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0026904

Description

Publication

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Inhibition of Aldosterone in Patients With Chronic Renal Disease

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