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Spironolactone in Diabetic Nephropathy

This study has been completed.
Sponsor:
Information provided by:
Steno Diabetes Center
ClinicalTrials.gov Identifier:
NCT00317954
First received: April 21, 2006
Last updated: NA
Last verified: August 2005
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Spironolactone in Diabetic Nephropathy

Resource links provided by NLM:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: April 21, 2006
Last Updated: April 21, 2006
Health Authority: Denmark: Ethics Committee
Denmark: Danish Medicines Agency

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
Aldosterone Antagonists
 Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013