Spironolactone in Diabetic Nephropathy - Full Text View

Sponsor:	Steno Diabetes Center
Information provided by:	Steno Diabetes Center
ClinicalTrials.gov Identifier:	NCT00317954

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 IV

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetic Kidney Problems

Drug Information available for: Spironolactone

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:

Schjoedt KJ, Rossing K, Juhl TR, Boomsma F, Rossing P, Tarnow L, Parving HH. Beneficial impact of spironolactone in diabetic nephropathy. Kidney Int. 2005 Dec;68(6):2829-36.

Rossing K, Schjoedt KJ, Smidt UM, Boomsma F, Parving HH. Beneficial effects of adding spironolactone to recommended antihypertensive treatment in diabetic nephropathy: a randomized, double-masked, cross-over study. Diabetes Care. 2005 Sep;28(9):2106-12.

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 February 09, 2012