- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00317954
Spironolactone in Diabetic Nephropathy
April 21, 2006 updated by: Steno Diabetes Center Copenhagen
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.
Study Overview
Study Type
Interventional
Enrollment
48
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Gentofte, Denmark, 2820
- Steno Diabetes center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Changes in albuminuria
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Changes in blood pressure
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Secondary Outcome Measures
Outcome Measure |
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Changes in glomerular filtration rate
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Hans-Henrik Parving, MD,DMSc,Prof, Steno Diabetes Center Copenhagen
- Principal Investigator: Katrine J Schjoedt, MD, Steno Diabetes Center Copenhagen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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. doi: 10.1111/j.1523-1755.2005.00756.x.
- 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. doi: 10.2337/diacare.28.9.2106.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2003
Study Completion
July 1, 2005
Study Registration Dates
First Submitted
April 21, 2006
First Submitted That Met QC Criteria
April 21, 2006
First Posted (Estimate)
April 25, 2006
Study Record Updates
Last Update Posted (Estimate)
April 25, 2006
Last Update Submitted That Met QC Criteria
April 21, 2006
Last Verified
August 1, 2005
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urologic Diseases
- Endocrine System Diseases
- Diabetes Complications
- Diabetes Mellitus
- Kidney Diseases
- Diabetic Nephropathies
- Physiological Effects of Drugs
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Natriuretic Agents
- Diuretics
- Hormone Antagonists
- Mineralocorticoid Receptor Antagonists
- Diuretics, Potassium Sparing
- Spironolactone
Other Study ID Numbers
- 2612-2233
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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