Chronic Kidney DiseasePhase 2/3HerculesNCT00169923
Anti-Inflammatory Effects of Rosiglitazone in Patients With Stage 4 and 5 Chronic Kidney Disease
A Phase 2/3 study testing rosiglitazone in people with Chronic Kidney Disease and Inflammation, run by Leiden University Medical Center at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Inflammation
- What is being tested?
- rosiglitazone
- How many people
- 200 participants
- Where
- 2 sitesNetherlands
- Study dates
- Apr 2007to May 2009
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written consent
- Over 18 years of age
- Stage 4 or 5 chronic kidney disease according the K/DOQI guidelines
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Medisch Centrum Haaglanden
The Hague, Z-Holland, 2512va
Haga Ziekenhuis
The Hague, Z-Holland, 2545ch
About this study
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.
Read the detailed description
This is a double-blind randomised placebo-controlled clinical multicenter trial in patients with stage 4 and 5 chronic kidney disease. Eligible patients in the outpatient kidney clinic and patients at the dialysis department will be informed by their treating physician about the study and they will be asked to join the study. Following informed consent the eligible patients will undergo baseline evaluation and will then be followed for a period of 48 weeks. Patients will be randomly divided in two groups: one group will take rosiglitazone (4 mg during the first 8 weeks once daily and 8 mg during the next 40 weeks once daily) and the other group will get placebo. The original medication will be continued. The total follow-up will be 48 weeks.
At the start of the study and at 4, 8, 12, 18, 24 and 48 weeks during follow-up inflammatory parameters (CRP, hs CRP, fetuin, fibrinogen), lipid profile,iron status, glucose and insulin will be measured. Intima media thickness, pulse wave velocity, bone densitometry,subjective global assessment will be performed at 0, 24 and 48 weeks.
- Conditions
- Chronic Kidney Disease, Inflammation
- Being tested
- rosiglitazone
- Medical subject headings
- Renal Insufficiency, Chronic, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rosiglitazoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
intima media thickness
Measured: 48 weeks
Secondary outcomes (7)
carotid artery calcifications
Measured: 48 weeks
inflammation
Measured: 48 weeks
lipid profile
Measured: 48 weeks
metabolic profile
Measured: 48 weeks
pulse wave velocity
Measured: 48 weeks
nutritional status
Measured: 48 weeks
bone density
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startApr 2007
- Study completionMay 2009 (estimated)
Why it stopped: it was not possible to recruit any patient in the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- andré gaasbeek, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00169923
- Sponsor's protocol ID
- P06.108
- Acronym
- Hercules
- Status last verified
- Sep 2008
- First submitted
- 13 Sep 2005
- Last updated
- 1 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-Inflammatory Effects of Rosiglitazone in Patients With Stage 4 and 5 Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT00169923
- Acronym / sponsor ID
- Hercules / P06.108
- Conditions
- Chronic Kidney Disease, Inflammation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: it was not possible to recruit any patient in the study
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- Apr 2007
- Study completion
- May 2009 (estimated)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a double-blind randomised placebo-controlled clinical multicenter trial in patients with stage 4 and 5 chronic kidney disease. Eligible patients in the outpatient kidney clinic and patients at the dialysis department will be informed by their treating physician about the study and they will be asked to join the study. Following informed consent the eligible patients will undergo baseline evaluation and will then be followed for a period of 48 weeks. Patients will be randomly divided in two groups: one group will take rosiglitazone (4 mg during the first 8 weeks once daily and 8 mg during the next 40 weeks once daily) and the other group will get placebo. The original medication will be continued. The total follow-up will be 48 weeks.
At the start of the study and at 4, 8, 12, 18, 24 and 48 weeks during follow-up inflammatory parameters (CRP, hs CRP, fetuin, fibrinogen), lipid profile,iron status, glucose and insulin will be measured. Intima media thickness, pulse wave velocity, bone densitometry,subjective global assessment will be performed at 0, 24 and 48 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written consent
- Over 18 years of age
- Stage 4 or 5 chronic kidney disease according the K/DOQI guidelines
Key exclusion criteria (7 listed)
- Life span of less than one year
- Alcohol abuse
- Transaminases > 2.5 times the upper limit
- Diabetes mellitus
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rosiglitazone | Drug | – |
Primary outcome
intima media thickness
Time frame: 48 weeks
7 secondary outcomes
carotid artery calcifications
Time frame: 48 weeks
inflammation
Time frame: 48 weeks
lipid profile
Time frame: 48 weeks
metabolic profile
Time frame: 48 weeks
pulse wave velocity
Time frame: 48 weeks
nutritional status
Time frame: 48 weeks
bone density
Time frame: 48 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
andré gaasbeek principal investigator
Leiden University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing rosiglitazone in people with Chronic Kidney Disease and Inflammation, run by Leiden University Medical Center at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intima media thickness (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2008.