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Spironolactone in Diabetic Nephropathy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00317954
First Posted: April 25, 2006
Last Update Posted: April 25, 2006
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.
Information provided by:
Steno Diabetes Center
  Purpose
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 Intervention Phase
Diabetic Nephropathy Drug: Spironolactone Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Spironolactone in Diabetic Nephropathy

Resource links provided by NLM:


Further study details as provided by Steno Diabetes Center:

Primary Outcome Measures:
  • Changes in albuminuria
  • Changes in blood pressure

Secondary Outcome Measures:
  • Changes in glomerular filtration rate

Estimated Enrollment: 48
Study Start Date: September 2003
Estimated Study Completion Date: July 2005
  Eligibility

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
Criteria

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
  Contacts and Locations
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


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

Publications:
ClinicalTrials.gov Identifier: NCT00317954     History of Changes
Other Study ID Numbers: 2612-2233
First Submitted: April 21, 2006
First Posted: April 25, 2006
Last Update Posted: April 25, 2006
Last Verified: August 2005

Keywords provided by Steno Diabetes Center:
Diabetic nephropathy
Spironolactone
Aldosterone antagonism
Renoprotection

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


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