Inhibition of Aldosterone in Patients With Chronic Renal Disease

Kidney Failure, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00430924
• Other study ID #: B109LB1
• Secondary ID: 2006-004411-21
• Status: Completed
• Phase: Phase 4
• First received: February 1, 2007
• Last updated: February 7, 2012
• Start date: March 2007
• Est. completion date: August 2009

Study information

• Verified date: February 2012
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: Danish Dataprotection AgencyUnited States: Food and Drug AdministrationDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Drug:
• Eplerenone
Once daily administration for 8 weeks and 8 weeks control.

Locations

Country	Name	City	State
Denmark	Rigshospitalet, Blegdamsvej 9	Copenhagen
Denmark	Herlev Hospital	Herlev

Sponsors (2)

Lead Sponsor	Collaborator
Lene Boesby	Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proteinuria reduction		bi-monthly	No
Secondary	Evaluating blood pressure response and hyperkalaemia after aldosterone inhibition.		weekly	Yes

External Links

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