Endstage Renal DiseaseNCT00745914
Peroxisome Proliferator-Activated Receptor-gamma (PPAR-gamma) Agonist in Diabetic End-Stage Renal Disease Patients
A study testing Pioglitazone in people with Endstage Renal Disease and Diabetes, run by The University of Hong Kong at 2 sites in Hong Kong.
Trial summary
To test the hypothesis that PPAR-gamma agonist, rosiglitazone, induces carotid plaque regression in diabetic ESRD patients on maintenance PD via its anti-inflammatory property. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Endstage Renal Disease, Diabetes
- What is being tested?
- Pioglitazone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 2 sitesHong Kong
- Study dates
- Sep 2008to Dec 2013
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetic ESRD patients receiving long-term PD treatment, with carotid plaque (defined as focal intima-media thickening >1mm) present on screening ultrasonography
- Patients who provide informed consent for the study
Who cannot join
- Patients with systemic inflammatory disease such as systemic lupus erythematosus
- Patients with chronic liver disease or cirrhosis
- Patients with current active malignancy
- Patients with chronic rheumatic heart disease or congenital heart disease
- Patients with poor general condition
- Patients with plan for living related kidney transplant within coming 1 year
Show all 11Show fewer
- Patients with pre-existing class III/IV heart failure,
- Patients with recurrent hypoglycemia
- Patients already on glitazone treatment
- Female patients with pregnancy
- Patients with contraindications for MRI examination including those with pacemaker or metallic implant.
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites
Queen Mary Hospital and Tung Wah Hospital
Hong Kong, Hong Kong, 0000
Queen Mary Hospital, Tung Wah Hospital
Hong Kong, 0000
About this study
Official title: A Randomized Placebo-Controlled Study to Evaluate the Efficacy of Peroxisome Proliferator-Activated Receptor-gamma (PPAR-gamma) Agonist in Inducing Carotid Atherosclerotic Plaque Regression in Diabetic End-Stage Renal Disease Patients
To test the hypothesis that PPAR-gamma agonist, rosiglitazone, induces carotid plaque regression in diabetic ESRD patients on maintenance PD via its anti-inflammatory property.
Read the detailed description
End-stage renal disease (ESRD) patients are at an increased risk of accelerated atherosclerosis and cardiovascular morbidity and mortality. Non-traditional risk factors such as inflammation and insulin resistance have important contributions to accelerated atherosclerosis in ESRD patients receiving long-term peritoneal dialysis (PD). The peroxisome proliferator-activated receptor-g (PPAR-g) is a member of the nuclear receptor family of ligand-dependent transcription factors. Activation of the PPAR-g has been shown in both clinical and experimental studies to have anti-inflammatory and anti-atherosclerotic properties other than insulin-sensitizing effects. Recent study also showed that PPAR-g agonists reduce plaque inflammation by inhibiting the activation of proinflammatory genes responsible for plaque development and growth. Hence, this study aims to examine the effects of PPAR-g activation on the progression of carotid plaque in diabetic ESRD patients receiving long-term PD using high-resolution magnetic resonance imaging (MRI).
- Conditions
- Endstage Renal Disease, Diabetes
- Being tested
- Pioglitazone, Placebo comparator
- Keywords
- PPAR-gamma, diabetic, kidney disease, atherosclerosis
- Medical subject headings
- Diabetes Mellitus, Kidney Diseases, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PioglitazoneDrug
Also called Actos
oral Pioglitazone 15mg daily for 12 weeks, then 30mg daily for 36 weeks
Placebo comparatorDrug
Also called Placebo
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Pioglitazone drug 15mg daily for 3 months then 30mg for 9 months (Peroxisome Proliferator-Activated Receptor-gamma agonist) Receives: Drug: Pioglitazone |
| 2 | Placebo comparator | placebo comparator drug 15mg daily for 3months, then 30mg for 9 months Receives: Drug: Placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in carotid plaque volume
Measured: 12 months
Secondary outcomes (1)
Change in inflammatory markers include C-reactive protein, interleukin-6, adiponectin, metalloproteinases
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionSep 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endstage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Angela Yee-Moon Wang, The University of Hong Kong
- Investigators
- Angela YM Wang, MD, FRCP, Principal investigator, Queen Mary Hospital, University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00745914
- Sponsor's protocol ID
- A111-103
- Status last verified
- Jan 2017
- First submitted
- 1 Sep 2008
- Last updated
- 10 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Placebo-Controlled Study to Evaluate the Efficacy of Peroxisome Proliferator-Activated Receptor-gamma (PPAR-gamma) Agonist in Inducing Carotid Atherosclerotic Plaque Regression in Diabetic End-Stage Renal Disease Patients
- ClinicalTrials.gov ID
- NCT00745914
- Acronym / sponsor ID
- A111-103
- Conditions
- Endstage Renal Disease, Diabetes
- Keywords
- PPAR-gamma, diabetic, kidney disease, atherosclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Sep 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 3 Sep 2008 (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.
To test the hypothesis that PPAR-gamma agonist, rosiglitazone, induces carotid plaque regression in diabetic ESRD patients on maintenance PD via its anti-inflammatory property.
Detailed description
End-stage renal disease (ESRD) patients are at an increased risk of accelerated atherosclerosis and cardiovascular morbidity and mortality. Non-traditional risk factors such as inflammation and insulin resistance have important contributions to accelerated atherosclerosis in ESRD patients receiving long-term peritoneal dialysis (PD). The peroxisome proliferator-activated receptor-g (PPAR-g) is a member of the nuclear receptor family of ligand-dependent transcription factors. Activation of the PPAR-g has been shown in both clinical and experimental studies to have anti-inflammatory and anti-atherosclerotic properties other than insulin-sensitizing effects. Recent study also showed that PPAR-g agonists reduce plaque inflammation by inhibiting the activation of proinflammatory genes responsible for plaque development and growth. Hence, this study aims to examine the effects of PPAR-g activation on the progression of carotid plaque in diabetic ESRD patients receiving long-term PD using high-resolution magnetic resonance imaging (MRI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: PioglitazonePioglitazone drug 15mg daily for 3 months then 30mg for 9 months (Peroxisome Proliferator-Activated Receptor-gamma agonist) |
| 2 | Placebo comparator | Drug: Placebo comparatorplacebo comparator drug 15mg daily for 3months, then 30mg for 9 months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diabetic ESRD patients receiving long-term PD treatment, with carotid plaque (defined as focal intima-media thickening >1mm) present on screening ultrasonography
- Patients who provide informed consent for the study
Key exclusion criteria (11 listed)
- Patients with systemic inflammatory disease such as systemic lupus erythematosus
- Patients with chronic liver disease or cirrhosis
- Patients with current active malignancy
- Patients with chronic rheumatic heart disease or congenital heart disease
- Patients with poor general condition
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 |
|---|---|---|
| PioglitazoneAlso: Actosoral Pioglitazone 15mg daily for 12 weeks, then 30mg daily for 36 weeks | Drug | 1 |
| Placebo comparatorAlso: PlaceboPlacebo comparator | Drug | 2 |
Primary outcome
Change in carotid plaque volume
Time frame: 12 months
1 secondary outcome
Change in inflammatory markers include C-reactive protein, interleukin-6, adiponectin, metalloproteinases
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2017.
- Individual participant dataSharing planned: No
Related trials for Endstage Renal Disease
Recruiting
Effect of Apiban Therapy on AVF Maturation in ESRD Patients
Endstage Renal Disease, Direct Oral Anticoagulants (DOACs)
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 YM Wang, MD, FRCP principal investigator
Queen Mary Hospital, 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 Pioglitazone in people with Endstage Renal Disease and Diabetes, run by The University of Hong Kong at 2 sites in Hong Kong.
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 2 inclusion and 11 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: finished, as of the sponsor's last update on 10 Jan 2017. 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 Hong Kong. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in carotid plaque volume (time frame: 12 months). 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 10 Jan 2017.