The Effect of Aldosterone Inhibition on Proteinuria in Patients With Progressive Renal Disease
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 42
- Locations
- 2
- Primary Endpoint
- Proteinuria reduction
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
1
Eplerenone
Intervention: Eplerenone (Drug)
2
Control
Intervention: Eplerenone (Drug)
Outcomes
Primary Outcomes
Proteinuria reduction
Time Frame: bi-monthly
Secondary Outcomes
- Evaluating blood pressure response and hyperkalaemia after aldosterone inhibition.(weekly)
Investigators
Lene Boesby
MD
Herlev Hospital