NCT00497666

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

July 6, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 9, 2007

Completed
23 days until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

July 9, 2007

Status Verified

July 1, 2007

First QC Date

July 6, 2007

Last Update Submit

July 6, 2007

Conditions

DiabetesDiabetic NephropathyRenal Protection

Keywords

DiabetesDiabetic nephropathyrenal protection

Interventions

Rosiglitasone (retrospective observation)DRUG

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Insulin Therapy at baseline
  • Malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clalit Health Cervices, Central District

Ẕerifin, 70300, Israel

Location

MeSH Terms

Conditions

Diabetes MellitusDiabetic Nephropathies

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes Complications

Study Officials

  • Leonid S Feldman

    Nephrology Division, Assaf Harofeh Medical Center, Zerifin,

    PRINCIPAL INVESTIGATOR

  • Leonid S Feldman

    Assaf-Harofeh Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Leonid S Feldman

CONTACT

+972-8-9779383leonidf@asaf.health.gov.il

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 6, 2007

First Posted

July 9, 2007

Study Start

August 1, 2007

Study Completion

December 1, 2007

Last Updated

July 9, 2007

Record last verified: 2007-07

Locations

IL(1)