Chronic DiseaseNCT00516880
Targeting Peroxisome Proliferator-activated Receptor-gamma in Peritoneal Dialysis Patients - Will it Reduce Inflammation, Atherosclerosis, Calcification and Improve Survival of Peritoneal Dialysis Patients?
A study testing rosiglitazone in people with Chronic Disease and Kidney Diseases, run by Hospital Authority, Hong Kong at 2 sites in China.
Trial summary
Peritoneal dialysis patients are at increased risk of cardiovascular morbidity and mortality and are related to the presence of accelerated atherosclerosis. Our recent data showed that inflammation predicts mortality and cardiovascular death, independent of other cardiovascular risk factors in peritoneal dialysis… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Chronic Disease, Kidney Diseases, Cardiovascular Diseases
- What is being tested?
- rosiglitazone
- How many people
- 160 participants
- Where
- 2 sitesChina
- Study dates
- Mar 2006to Nov 2008
- Phase
- Interventional
- 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 20 to 75 years
- All sexes
- Adult, Older adult
Who may be able to join
- Both prevalent patients or patients newly started on continuous ambulatory peritoneal dialysis with age between 20 - 75 with or without diabetes mellitus will be considered eligible for study entry. For patients newly started on continuous ambulatory peritoneal dialysis, they will be suitable for recruitment into the study after one month on continuous ambulatory peritoneal dialysis.
Who cannot join
- Patients with underlying malignancy
- Patients with chronic liver disease or liver cirrhosis
- Patients with hepatitis B or C positive
- Patients with active infections
- Patients with other chronic active inflammatory disease such as systemic lupus erythematosus, rheumatoid arthritis
- Patients who refuse study participation
Show all 13Show fewer
- Patients with underlying congenital heart disease or rheumatic heart disease
- Patients with poor general condition
- Patients with plans for living related kidney transplant within 2 years
- Female patients with pregnancy
- Patients with history of recurrent hypoglycemia
- Patients with Class III and IV congestive heart failure
- Patients already receiving glitazones treatment at the screening visit
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Department of Medicine, Queen Mary Hospital
Hong Kong
KN Lai, Prof
- Recruiting
Department of Medicine, Tung Wah Hospital
Hong Kong
WK Lo, Dr
About this study
Peritoneal dialysis patients are at increased risk of cardiovascular morbidity and mortality and are related to the presence of accelerated atherosclerosis. Our recent data showed that inflammation predicts mortality and cardiovascular death, independent of other cardiovascular risk factors in peritoneal dialysis patients. As a considerable proportion of peritoneal dialysis patients showed evidence of inflammation, it raises an important question as to whether anti-inflammatory treatment has any cardiovascular and survival benefit in these patients. The peroxisome proliferator-activated receptor-gamma (PPAR-g) agonist is a class of drug with insulin sensitizing property. Recent experimental and clinical studies demonstrated that this class of drug has anti-inflammatory and anti-atherosclerotic properties other than insulin sensitizing effect in type 2 diabetics. We therefore hypothesize that modulation of the PPAR-g activity may be a novel therapeutic strategy for reducing inflammation and retarding the progression of atherosclerosis and possibly lowering mortality in our peritoneal dialysis patients.
- Conditions
- Chronic Disease, Kidney Diseases, Cardiovascular Diseases
- Being tested
- rosiglitazone
- Keywords
- chronic kidney disease, cardiovascular disease
- Medical subject headings
- Chronic Disease, Kidney Diseases, Cardiovascular Diseases, Renal Insufficiency, Chronic
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.
carotid athersclerosis
Measured: 6 month, 1 year and 2 year
endothelial function
Measured: 6 month, 1 year and 2 year
Secondary outcomes (3)
all-cause mortality and cardiovascular event
Measured: 1 year, 2 year
pulse wave velocity
Measured: 6 month, 1 year, 2 year
inflammation
Measured: 6 month, 1 year, 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2007 (estimated)
- Study startMar 2006
- Study completionNov 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Authority, Hong Kong
- Sponsor type
- Other government
- Investigators
- Angela Wang, Dr, Principal investigator, Department of Medicine/Nephrology, Queen Mary Hospital/ The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00516880
- Sponsor's protocol ID
- UW05-236T/899
- Other IDs
- HARECCTR0500007
- Status last verified
- Jul 2010
- First submitted
- 15 Aug 2007
- Last updated
- 7 Jul 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Peroxisome Proliferator-activated Receptor-gamma in Peritoneal Dialysis Patients - Will it Reduce Inflammation, Atherosclerosis, Calcification and Improve Survival of Peritoneal Dialysis Patients?
- ClinicalTrials.gov ID
- NCT00516880
- Acronym / sponsor ID
- UW05-236T/899
- Conditions
- Chronic Disease, Kidney Diseases, Cardiovascular Diseases
- Keywords
- chronic kidney disease, cardiovascular disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Hospital Authority, Hong KongOther government
- Study start
- Mar 2006
- Study completion
- Nov 2008 (estimated)
- First posted
- 16 Aug 2007 (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.
Peritoneal dialysis patients are at increased risk of cardiovascular morbidity and mortality and are related to the presence of accelerated atherosclerosis. Our recent data showed that inflammation predicts mortality and cardiovascular death, independent of other cardiovascular risk factors in peritoneal dialysis patients. As a considerable proportion of peritoneal dialysis patients showed evidence of inflammation, it raises an important question as to whether anti-inflammatory treatment has any cardiovascular and survival benefit in these patients. The peroxisome proliferator-activated receptor-gamma (PPAR-g) agonist is a class of drug with insulin sensitizing property. Recent experimental and clinical studies demonstrated that this class of drug has anti-inflammatory and anti-atherosclerotic properties other than insulin sensitizing effect in type 2 diabetics. We therefore hypothesize that modulation of the PPAR-g activity may be a novel therapeutic strategy for reducing inflammation and retarding the progression of atherosclerosis and possibly lowering mortality in our peritoneal dialysis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Both prevalent patients or patients newly started on continuous ambulatory peritoneal dialysis with age between 20 - 75 with or without diabetes mellitus will be considered eligible for study entry. For patients newly started on continuous ambulatory peritoneal dialysis, they will be suitable for recruitment into the study after one month on continuous ambulatory peritoneal dialysis.
Key exclusion criteria (13 listed)
- Patients with underlying malignancy
- Patients with chronic liver disease or liver cirrhosis
- Patients with hepatitis B or C positive
- Patients with active infections
- Patients with other chronic active inflammatory disease such as systemic lupus erythematosus, rheumatoid arthritis
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
carotid athersclerosis
Time frame: 6 month, 1 year and 2 year
endothelial function
Time frame: 6 month, 1 year and 2 year
3 secondary outcomes
all-cause mortality and cardiovascular event
Time frame: 1 year, 2 year
pulse wave velocity
Time frame: 6 month, 1 year, 2 year
inflammation
Time frame: 6 month, 1 year, 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2010.
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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.
Angela Wang, Dr principal investigator
Department of Medicine/Nephrology, Queen Mary Hospital/ The University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rosiglitazone in people with Chronic Disease and Kidney Diseases, run by Hospital Authority, Hong Kong at 2 sites in China.
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 1 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 7 Jul 2010. 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 China. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Angela Wang, Dr ((852) 2855 4949, aw2000_hk@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
carotid athersclerosis (time frame: 6 month, 1 year and 2 year). The study lists 2 primary outcomes in all. 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 7 Jul 2010.