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Spironolactone in Diabetic Nephropathy

Spironolactone in Diabetic Nephropathy

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00317954
Enrollment
48
Registered
2006-04-25
Start date
2003-09-30
Completion date
2005-07-31
Last updated
2006-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Nephropathy

Keywords

Diabetic nephropathy, Spironolactone, Aldosterone antagonism, Renoprotection

Brief 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.

Interventions

DRUGSpironolactone

Sponsors

Steno Diabetes Center Copenhagen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Changes in albuminuria
Changes in blood pressure

Secondary

MeasureTime frame
Changes in glomerular filtration rate

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026