Association Between Rosiglitazone Use and Clinical Course of Diabetic Nephropathy: Population-Based Study

This study is not yet open for participant recruitment.

Verified by Assaf-Harofeh Medical Center, July 2007

First Received: July 6, 2007 No Changes Posted

Sponsored by:	Assaf-Harofeh Medical Center
Information provided by:	Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:	NCT00497666

Purpose

Recent data show that Rosiglitazone treatment can reduce proteinuria in diabetic patients. However, currently there are no trials that examine the effects of Rosiglitazone on kidney disease progression, that is, doubling of serum creatinine or time to onset of end-stage renal disease, in patients with diabetic nephropathy. We decided to study retrospectively the possible association between rosiglitazone use and clinical course of diabetic nephropathy, including rate of deterioration of renal function, appearance and progression of microalbuminuria/proteinuria, survival and acceptance to renal replacement therapy.

Condition	Intervention
Diabetes Diabetic Nephropathy Renal Protection	Drug: Rosiglitasone (retrospective observation)

MedlinePlus related topics: Diabetes Diabetic Kidney Problems

Drug Information available for: Rosiglitazone Rosiglitazone Maleate

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cross-Sectional, Case Control, Retrospective Study
Official Title:	Retrospective Study Evaluating the Association Between Rosiglitazone Use and Clinical Course of Diabetic Nephropathy: Population-Based Study

Further study details as provided by Assaf-Harofeh Medical Center:

Study Start Date:	August 2007
Estimated Study Completion Date:	December 2007

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Diagnosis of Diabetes Mellitus Type II
Treatment With Oral hypoglycemics
Availability of Baseline and follow up clinical data

Exclusion Criteria:

Insulin Therapy at baseline
Malignancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00497666

Contacts

Contact: Leonid S Feldman

+972-8-9779383 ext 9383

leonidf@asaf.health.gov.il

Locations

Israel
Clalit Health Cervices, Central District
Zerifin,, Israel, 70300

Sponsors and Collaborators

Assaf-Harofeh Medical Center

Investigators

Principal Investigator:	Leonid S Feldman	Nephrology Division, Assaf Harofeh Medical Center, Zerifin,
Principal Investigator:	Leonid S Feldman	Assaf-Harofeh Medical Center
Principal Investigator:	Leonid S Feldman	Nephrology Division, Assaf Harofeh Medical Center, Zerifin,

More Information

No publications provided

Study ID Numbers:	346147Rosi
Study First Received:	July 6, 2007
Last Updated:	July 6, 2007
ClinicalTrials.gov Identifier:	NCT00497666 History of Changes
Health Authority:	Israel: Ministry of Health

Keywords provided by Assaf-Harofeh Medical Center:

Diabetes
Diabetic nephropathy
renal protection

Study placed in the following topic categories:

Hypoglycemic Agents
Diabetic Nephropathies
Urologic Diseases
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Kidney Diseases
Rosiglitazone
Diabetes Complications

Additional relevant MeSH terms:

Hypoglycemic Agents
Diabetic Nephropathies
Urologic Diseases
Physiological Effects of Drugs
Diabetes Mellitus

Endocrine System Diseases
Kidney Diseases
Rosiglitazone
Pharmacologic Actions
Diabetes Complications

ClinicalTrials.gov processed this record on May 07, 2009