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Inhibition of Aldosterone in Patients With Chronic Renal Disease

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ClinicalTrials.gov Identifier: NCT00430924
Recruitment Status : Completed
First Posted : February 2, 2007
Last Update Posted : February 8, 2012
Sponsor:
Collaborator:
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Lene Boesby, Herlev Hospital

Tracking Information
First Submitted Date  ICMJE February 1, 2007
First Posted Date  ICMJE February 2, 2007
Last Update Posted Date February 8, 2012
Study Start Date  ICMJE March 2007
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2009)
Proteinuria reduction [ Time Frame: bi-monthly ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 1, 2007)
Proteinuria reduction
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2009)
Evaluating blood pressure response and hyperkalaemia after aldosterone inhibition. [ Time Frame: weekly ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2007)
Evaluating blood pressure response and hyperkalaemia after aldosterone inhibition.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Inhibition of Aldosterone in Patients With Chronic Renal Disease
Official Title  ICMJE The Effect of Aldosterone Inhibition on Proteinuria in Patients With Progressive Renal Disease
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Kidney Failure, Chronic
Intervention  ICMJE Drug: Eplerenone
Once daily administration for 8 weeks and 8 weeks control.
Study Arms  ICMJE
  • Active Comparator: 1
    Eplerenone
    Intervention: Drug: Eplerenone
  • No Intervention: 2
    Control
    Intervention: Drug: Eplerenone
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 7, 2012)
42
Original Enrollment  ICMJE
 (submitted: February 1, 2007)
40
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00430924
Other Study ID Numbers  ICMJE B109LB1
2006-004411-21
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lene Boesby, Herlev Hospital
Study Sponsor  ICMJE Lene Boesby
Collaborators  ICMJE Rigshospitalet, Denmark
Investigators  ICMJE
Study Director: Svend Strandgaard, DMSc
Study Director: Anne-Lise Kamper, DMSc nonaffiliated
PRS Account Herlev Hospital
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP