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Spironolactone in Diabetic Nephropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00317954
Recruitment Status : Completed
First Posted : April 25, 2006
Last Update Posted : April 25, 2006
Sponsor:
Information provided by:
Steno Diabetes Center Copenhagen

Tracking Information
First Submitted Date  ICMJE April 21, 2006
First Posted Date  ICMJE April 25, 2006
Last Update Posted Date April 25, 2006
Study Start Date  ICMJE September 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2006)
  • Changes in albuminuria
  • Changes in blood pressure
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 21, 2006)		 Changes in glomerular filtration rate
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Spironolactone in Diabetic Nephropathy
Official Title  ICMJE Spironolactone in Diabetic Nephropathy
Brief Summary The aim of the study was to evaluate the renoprotective effect (i.e. albuminuria- and bloodpressure lowering effect) of spironolactone 25 mg o.d. in type 1 and type 2 diabetic patients with albuminuria despite recommended antihypertensive treatment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Diabetic Nephropathy
Intervention  ICMJE Drug: Spironolactone
Study Arms  ICMJE Not Provided
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
Enrollment  ICMJE
 (submitted: April 21, 2006)		 48
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE July 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diabetes Mellitus
  • Diabetic Nephropathy
  • Glomerular filtration rate > 30 ml/min/1.73 m2
  • Blood pressure > 130/80 mm Hg

Exclusion Criteria:

  • Child bearing potential
  • Plasma-potassium >4.5 mmol/l
  • Breastfeeding
  • Abuse of alcohol or drugs
  • Non-diabetic kidney disease
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 NCT00317954
Other Study ID Numbers  ICMJE 2612-2233
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Steno Diabetes Center Copenhagen
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Hans-Henrik Parving, MD,DMSc,Prof Steno Diabetes Center Copenhagen
Principal Investigator: Katrine J Schjoedt, MD Steno Diabetes Center Copenhagen
PRS Account Steno Diabetes Center Copenhagen
Verification Date August 2005

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