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Inhibition of Aldosterone in Patients With Chronic Renal Disease

L

Lene Boesby

Status and phase

Completed
Phase 4

Conditions

Kidney Failure, Chronic

Treatments

Drug: Eplerenone

Study type

Interventional

Funder types

Other

Identifiers

NCT00430924
2006-004411-21
B109LB1

Details and patient eligibility

About

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.

Full 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.

Enrollment

42 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

42 participants in 2 patient groups

1
Active Comparator group
Description:
Eplerenone
Treatment:
Drug: Eplerenone
2
No Intervention group
Description:
Control
Treatment:
Drug: Eplerenone

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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