Inhibition of Aldosterone in Patients With Chronic Renal Disease

February 7, 2012 updated by: Lene Boesby

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, DK-2100 Ø
        • Rigshospitalet, Blegdamsvej 9
      • Herlev, Denmark, DK-2730
        • Herlev Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 2
Control
Drug: Eplerenone
Once daily administration for 8 weeks and 8 weeks control.
Active Comparator: 1
Eplerenone
Drug: Eplerenone
Once daily administration for 8 weeks and 8 weeks control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proteinuria reduction
Time Frame: bi-monthly
bi-monthly

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluating blood pressure response and hyperkalaemia after aldosterone inhibition.
Time Frame: weekly
weekly

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lene Boesby

Collaborators

Rigshospitalet, Denmark

Investigators

  • Study Director: Svend Strandgaard, DMSc
  • Study Director: Anne-Lise Kamper, DMSc, nonaffiliated

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

February 1, 2007

First Submitted That Met QC Criteria

February 1, 2007

First Posted (Estimate)

February 2, 2007

Study Record Updates

Last Update Posted (Estimate)

February 8, 2012

Last Update Submitted That Met QC Criteria

February 7, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B109LB1
  • 2006-004411-21

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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