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Completed

NCT Number: NCT00430924

Inhibition of Aldosterone in Patients With Chronic 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.

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Key information

Conditions

Kidney Failure, Chronic Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Proteinuria Renal Insufficiency Renal Insufficiency, Chronic Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rigshospitalet, Blegdamsvej 9, Copenhagen, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eplerenone

Drug

Once daily administration for 8 weeks and 8 weeks control.

Primary outcomes

  1. Proteinuria reduction

    Time frame: bi-monthly

Secondary outcomes

  1. Evaluating blood pressure response and hyperkalaemia after aldosterone inhibition.

    Time frame: weekly

Sponsors and collaborators

Lead sponsor

Lene Boesby

Other

Collaborators

  • Rigshospitalet, Denmark

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Feb 2, 2007
Registry last updated
Feb 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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