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Spironolactone in Diabetic Nephropathy

Primary Purpose

Diabetic Nephropathy

Status

Completed

Phase

Phase 4

Locations

Denmark

Study Type

Interventional

Intervention

Spironolactone

About this trial

This is an interventional treatment trial for Diabetic Nephropathy focused on measuring Diabetic nephropathy, Spironolactone, Aldosterone antagonism, Renoprotection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Steno Diabetes Center

Outcomes

Primary Outcome Measures

Changes in albuminuria

Changes in blood pressure

Secondary Outcome Measures

Changes in glomerular filtration rate

Full Information

NCT ID

NCT00317954

First Posted

April 21, 2006

Last Updated

April 21, 2006

Sponsor

Steno Diabetes Center Copenhagen

1. Study Identification

Unique Protocol Identification Number

NCT00317954

Brief Title

Spironolactone in Diabetic Nephropathy

Official Title

Spironolactone in Diabetic Nephropathy

Study Type

Interventional

2. Study Status

Record Verification Date

August 2005

Overall Recruitment Status

Completed

Study Start Date

September 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

July 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Steno Diabetes Center Copenhagen

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Nephropathy

Keywords

Diabetic nephropathy, Spironolactone, Aldosterone antagonism, Renoprotection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

Double

Allocation

Randomized

Enrollment

48 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Spironolactone

Primary Outcome Measure Information:

Title

Changes in albuminuria

Title

Changes in blood pressure

Secondary Outcome Measure Information:

Title

Changes in glomerular filtration rate

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hans-Henrik Parving, MD,DMSc,Prof

Organizational Affiliation

Steno Diabetes Center Copenhagen

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Katrine J Schjoedt, MD

Organizational Affiliation

Steno Diabetes Center Copenhagen

Official's Role

Principal Investigator

Facility Information:

Facility Name

Steno Diabetes Center

City

Gentofte

ZIP/Postal Code

2820

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

16316360

Citation

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.

Results Reference

result

PubMed Identifier

16123474

Citation

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.

Results Reference

result

Learn more about this trial

Spironolactone in Diabetic Nephropathy

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