NCT00240019

Brief Summary

The angiotensin converting enzyme inhibitor drugs are now standard therapy for patients with diabetic nephropathy. The hypothesis of this study is that adding a diuretic agent (furosemide) will decrease the urine protein, which is a sign of disease, more than an angiotensin converting enzyme inhibitor alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2003

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

December 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

October 13, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

October 17, 2006

Status Verified

June 1, 2006

First QC Date

October 13, 2005

Last Update Submit

October 16, 2006

Conditions

Diabetic Nephropathy

Outcome Measures

Primary Outcomes (1)

  • The amount of protein in the urine after 8 weeks of treatment.

Secondary Outcomes (1)

  • The estimated glomerular filtration rate after 8 weeks of treatment.

Interventions

Addition of furosemide 20 mg oral bid to baseline regimenDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • proteinuria greater than 1 gram/day serum creatinine \< 2.6 for men, \< 2.0 for women

You may not qualify if:

  • blood pressure which cannot be controlled without a diuretic renal diseases other than diabetic nephropathy other disease which would alter renal function during 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kaiser Permanente of Northern California, Santa Clara and San Jose

Santa Clara, California, 95051, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Diabetic Nephropathies

Condition Hierarchy (Ancestors)

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

Study Officials

  • Timothy W Meyer, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 13, 2005

First Posted

October 17, 2005

Study Start

December 1, 2003

Study Completion

April 1, 2006

Last Updated

October 17, 2006

Record last verified: 2006-06

Locations

US(2)