Spironolactone in Diabetic Nephropathy
Information source: Steno Diabetes Center
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetic Nephropathy
Intervention: Spironolactone (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Steno Diabetes Center Official(s) and/or principal investigator(s):
Hans-Henrik Parving, MD,DMSc,Prof, Study Chair, Affiliation: Steno Diabetes Center
Katrine J Schjoedt, MD, Principal Investigator, Affiliation: Steno Diabetes Center
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.
Clinical Details
Official title: Spironolactone in Diabetic Nephropathy
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: Changes in albuminuriaChanges in blood pressure
Secondary outcome: Changes in glomerular filtration rate
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Steno Diabetes Center, Gentofte 2820, Denmark
Additional Information
Starting date: September 2003
Ending date: July 2005
Last updated: April 21, 2006
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