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Spironolactone in Diabetic Nephropathy

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ClinicalTrials.gov Identifier: NCT00317954
Recruitment Status : Completed
First Posted : April 25, 2006
Last Update Posted : April 25, 2006
Information provided by:
Steno Diabetes Center

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.

Condition or disease Intervention/treatment Phase
Diabetic Nephropathy Drug: Spironolactone Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Spironolactone in Diabetic Nephropathy
Study Start Date : September 2003
Estimated Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Changes in albuminuria
  2. Changes in blood pressure

Secondary Outcome Measures :
  1. Changes in glomerular filtration rate

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00317954

Steno Diabetes Center
Gentofte, Denmark, 2820
Sponsors and Collaborators
Steno Diabetes Center
Study Chair: Hans-Henrik Parving, MD,DMSc,Prof Steno Diabetes Center
Principal Investigator: Katrine J Schjoedt, MD Steno Diabetes Center

ClinicalTrials.gov Identifier: NCT00317954     History of Changes
Other Study ID Numbers: 2612-2233
First Posted: April 25, 2006    Key Record Dates
Last Update Posted: April 25, 2006
Last Verified: August 2005

Keywords provided by Steno Diabetes Center:
Diabetic nephropathy
Aldosterone antagonism

Additional relevant MeSH terms:
Diabetic Nephropathies
Kidney Diseases
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Natriuretic Agents