ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
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

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   

ChemIDplus related topics:   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  Show Detailed Description

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Insulin Therapy at baseline
  2. 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     Not yet recruiting
      Zerifin,, Israel, 70300
      Contact: Leonid S Feldman     +972-8-9779383 ext 9383     leonidf@asaf.health.gov.il    
      Contact: Leonid S Feldman     +972-8-9779383 ext 9383     leonidf@asaf.health.gov.il    
      Sub-Investigator: Shlomo Vinker, MD            

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


Study ID Numbers:   346147Rosi
First Received:   July 6, 2007
Last Updated:   July 6, 2007
ClinicalTrials.gov Identifier:   NCT00497666
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:
Diabetic Nephropathies
Urologic Diseases
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Kidney Diseases
Rosiglitazone
Diabetes Complications

Additional relevant MeSH terms:
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 06, 2008




Links to all studies - primarily for crawlers