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Spironolactone in Diabetic Nephropathy

Information source: Steno Diabetes Center
ClinicalTrials.gov processed this data on August 23, 2015
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome:

Changes in albuminuria

Changes 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
Last updated: April 21, 2006

Page last updated: August 23, 2015

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