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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by Assaf-Harofeh Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT00497666
First received: July 6, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
  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)

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

Resource links provided by NLM:

U.S. FDA Resources

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:

  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    
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
  More Information

No publications provided

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

Keywords provided by Assaf-Harofeh Medical Center:
Diabetes
Diabetic nephropathy
renal protection

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetic Nephropathies
Kidney Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Urologic Diseases
Diabetes Complications
Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013