NCT00452166

TerminatedPhase 3

Rosiglitazone and Insulin Resistance in Renally Impaired Pat...

Leiden University Medical Center Source

Leiden University Medical Center

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

p06-108a

Study Type

interventional

Estimated enrollment

30

Locations

1 country

Sites

1

Timeline

Study Start

April 2007

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

March 2008

Actual (reported)

Study Completion

May 2008

Actual (reported)

Brief Summary

30 non-diabetic, non-obese patients with stage 4 chronic kidney disease will be asked to participate in this metabolic study. The primary aim of this study is to determine the effect of rosiglitazone on insulin resistance in non-obese patients with non-diabetic stage 4 CKD. Secondary end points are the effects on inflammation (hsCRP), lipid profile, bone density and body composition.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Estimated enrollment: 30 participants
Study completion date: May 2008
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
March 26, 2007
Actual (reported)
First Posted
March 27, 2007
Actual (reported)
Study Start
April 2007
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
March 2008
Actual (reported)
Study Completion
May 2008
Actual (reported)

Last Updated: October 2, 2008
Status Verified: September 2008
Last Update Submitted: September 30, 2008

Conditions

Chronic Kidney Disease Insulin Resistance

Outcome Measures

Primary Outcomes (1)

Insulin sensitivity
12 weeks

Secondary Outcomes (4)

inflammation
12 weeks
lipid profile
12 weeks
bone density
12 weeks
body composition
12 weeks

Interventions

rosiglitazoneDrug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

CKD stage 4
BMI ≤ 30

Sponsors & Collaborators

Leiden University Medical Center
Otherlead

Study Sites (1)

LUMC

Leiden, Netherlands

MeSH Terms

Conditions

Renal Insufficiency, ChronicInsulin Resistance

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

Study Officials

andre gaasbeek, md
LUMC leiden
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: DOUBLE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER

Study Record Dates

First Submitted

March 26, 2007

First Posted

March 27, 2007

Study Start

April 2007

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

March 2008

Actual (reported)

NCT01150981

Effect of Rosiglitazone on the Vascular Biology of Human Fat Tissue

Phase 2Completed

NCT00465296

Ppar-Gamma EliminAtes Restenosis Longevity Study: PEARLS

Phase 3Terminated

NCT00550420

Study Of Rosiglitazone XR In Subjects With Mild-to-Moderate Alzheimers

Phase 3Terminated

NCT00428090

Rosiglitazone (Extended Release Tablets) As Monotherapy In Subjects With Mild To Moderate Alzheimer's Disease

Phase 3Completed

NCT00348140

Rosiglitazone (Extended Release Tablets) As Adjunctive Therapy In Subjects With Mild To Moderate Alzheimer's Disease

Phase 3Completed

NCT00240604

Prevention of Corticosteroid-induced Glucose Intolerance

Phase 3Unknown

Fasting glucose \< 7 mmol/l

You may not qualify if:

A diagnosis of diabetes mellitus for which the patient uses insulin
Significant co-morbidities which, according to the treating nephrologists, makes it unlikely that the patient will be able to complete the foreseen study period
Significant cardiovascular co-morbidities which are likely to interfere with the objectives of the study (morbid obesity, family history of dyslipidemia, etc.); at the discretion of the treating nephrologists or the principal investigator
Allergy for PPAR's
Cardiac disease with marked limitation of functional capacity (New York Heart Association III or IV clinical status)
Use of immunosuppressant agents
History of renal transplant
Hepatic insufficiency (defined as transaminase concentrations above \> 2.5 times the upper limit of normal for the laboratories)
A history of alcohol abuse or excessive alcohol use defined as more than 21 consumptions per week
For female patients: pregnancy, the intention to become pregnant within the study period, or lactating patients

Contact the study team to confirm eligibility.

Hyperinsulinism

Glucose Metabolism Disorders

Metabolic Diseases

Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Completion

May 2008

Actual (reported)

Last Updated

October 2, 2008

Record last verified: 2008-09

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00452166
Data provider: ClinicalTrials.gov
Source updated: 2008-10-02
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:26:32 UTC

Locations

NL(1)

Study Stopped

Rosiglitazone and Insulin Resistance in Renally Impaired Patients

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations