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Inhibition of Aldosterone in Patients With Chronic Renal Disease

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00430924
Enrollment
42
Registered
2007-02-02
Start date
2007-03-31
Completion date
2009-08-31
Last updated
2012-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Failure, Chronic

Keywords

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

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.

Interventions

DRUGEplerenone

Once daily administration for 8 weeks and 8 weeks control.

Sponsors

Rigshospitalet, Denmark
CollaboratorOTHER
Lene Boesby
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Proteinuria reductionbi-monthly

Secondary

MeasureTime frame
Evaluating blood pressure response and hyperkalaemia after aldosterone inhibition.weekly

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026