NCT00317954

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 25, 2006

Completed
Last Updated

April 25, 2006

Status Verified

August 1, 2005

First QC Date

April 21, 2006

Last Update Submit

April 21, 2006

Conditions

Diabetic Nephropathy

Keywords

Diabetic nephropathySpironolactoneAldosterone antagonismRenoprotection

Outcome Measures

Primary Outcomes (2)

  • Changes in albuminuria

  • Changes in blood pressure

Secondary Outcomes (1)

  • Changes in glomerular filtration rate

Interventions

SpironolactoneDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetes Mellitus
  • Diabetic Nephropathy
  • Glomerular filtration rate \> 30 ml/min/1.73 m2
  • Blood pressure \> 130/80 mm Hg

You may not qualify if:

  • Child bearing potential
  • Plasma-potassium \>4.5 mmol/l
  • Breastfeeding
  • Abuse of alcohol or drugs
  • Non-diabetic kidney disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Steno Diabetes Center

Gentofte Municipality, 2820, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 16316360RESULT

  • 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.

    PMID: 16123474RESULT

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

Spironolactone

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Hans-Henrik Parving, MD,DMSc,Prof

    Steno Diabetes Center Copenhagen

    STUDY CHAIR

  • Katrine J Schjoedt, MD

    Steno Diabetes Center Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 21, 2006

First Posted

April 25, 2006

Study Start

September 1, 2003

Study Completion

July 1, 2005

Last Updated

April 25, 2006

Record last verified: 2005-08

Locations

DK(1)