NCT00169923

Brief Summary

The purpose of this study in patients with stage 4 and 5 chronic kidney disease is to determine whether rosiglitazone can reduce inflammatory markers and to investigate its effect on intima media thickness, calcification and pulse wave velocity.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2007

Geographic Reach
1 country

2 active sites

Status
withdrawn

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

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
1.5 years until next milestone

Study Start

First participant enrolled

April 1, 2007

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

October 1, 2008

Status Verified

September 1, 2008

First QC Date

September 13, 2005

Last Update Submit

September 30, 2008

Conditions

Chronic Kidney DiseaseInflammation

Outcome Measures

Primary Outcomes (1)

  • intima media thickness

    48 weeks

Secondary Outcomes (7)

  • carotid artery calcifications

    48 weeks

  • inflammation

    48 weeks

  • lipid profile

    48 weeks

  • metabolic profile

    48 weeks

  • pulse wave velocity

    48 weeks

  • +2 more secondary outcomes

Interventions

rosiglitazoneDRUG

Eligibility Criteria

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

You may qualify if:

  • Written consent
  • Over 18 years of age
  • Stage 4 or 5 chronic kidney disease according the K/DOQI guidelines

You may not qualify if:

  • Life span of less than one year
  • Alcohol abuse
  • Transaminases \> 2.5 times the upper limit
  • Diabetes mellitus
  • Pregnancy
  • Cardiac disease with marked limitation of functional capacity (NYHA III or IV)
  • Use of immunosuppressant agents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medisch Centrum Haaglanden

The Hague, Z-Holland, 2512va, Netherlands

Location

Haga Ziekenhuis

The Hague, Z-Holland, 2545ch, Netherlands

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicInflammation

Interventions

Rosiglitazone

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • andré gaasbeek

    Leiden University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

April 1, 2007

Study Completion

May 1, 2009

Last Updated

October 1, 2008

Record last verified: 2008-09

Locations

NL(2)