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Inhibition of Aldosterone in Patients With Chronic Renal Disease

This study has been completed.
Sponsor:
Collaborator:
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Lene Boesby, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT00430924
First received: February 1, 2007
Last updated: February 7, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Kidney Failure, Chronic
 Drug: Eplerenone
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Effect of Aldosterone Inhibition on Proteinuria in Patients With Progressive Renal Disease

Resource links provided by NLM:

Drug Information available for: Eplerenone
U.S. FDA Resources

Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • Proteinuria reduction [ Time Frame: bi-monthly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluating blood pressure response and hyperkalaemia after aldosterone inhibition. [ Time Frame: weekly ] [ Designated as safety issue: Yes ]

Enrollment: 42
Study Start Date: March 2007
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Eplerenone
 Drug: Eplerenone
Once daily administration for 8 weeks and 8 weeks control.
No Intervention: 2
Control
 Drug: Eplerenone
Once daily administration for 8 weeks and 8 weeks control.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00430924

Locations
Denmark
Rigshospitalet, Blegdamsvej 9
Copenhagen, Denmark, DK-2100 Ø
Herlev Hospital
Herlev, Denmark, DK-2730
Sponsors and Collaborators
Lene Boesby
Rigshospitalet, Denmark
Investigators
Study Director: Svend Strandgaard, DMSc
Study Director: Anne-Lise Kamper, DMSc nonaffiliated
  More Information

Additional Information:
Publication  This link exits the ClinicalTrials.gov site

No publications provided by Herlev Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Lene Boesby, MD, Herlev Hospital
ClinicalTrials.gov Identifier: NCT00430924     History of Changes
Other Study ID Numbers: B109LB1, 2006-004411-21
Study First Received: February 1, 2007
Last Updated: February 7, 2012
Health Authority: Denmark: Danish Medicines Agency
Denmark: Danish Dataprotection Agency
United States: Food and Drug Administration
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Herlev Hospital:
Kidney Failure, Chronic
Proteinuria
Aldosterone
Renin-Angiotensin System

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Proteinuria
Renal Insufficiency
Urologic Diseases
Urination Disorders
Urological Manifestations
 Signs and Symptoms
Eplerenone
Aldosterone Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013