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Clinical Trials/NCT00430924
NCT00430924
Completed
Phase 4

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

Lene Boesby2 sites in 1 country42 target enrollmentMarch 2007

Overview

Phase
Phase 4
Intervention
Eplerenone
Conditions
Kidney Failure, Chronic
Sponsor
Lene Boesby
Enrollment
42
Locations
2
Primary Endpoint
Proteinuria reduction
Status
Completed
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2007
End Date
August 2009
Last Updated
14 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Lene Boesby
Responsible Party
Sponsor Investigator
Principal Investigator

Lene Boesby

MD

Herlev Hospital

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

Arms & Interventions

1

Eplerenone

Intervention: Eplerenone

2

Control

Intervention: Eplerenone

Outcomes

Primary Outcomes

Proteinuria reduction

Time Frame: bi-monthly

Secondary Outcomes

  • Evaluating blood pressure response and hyperkalaemia after aldosterone inhibition.(weekly)

Study Sites (2)

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