Chronic Kidney DiseaseNCT00586261
Does Thiazolidinedione Therapy Improve Endothelial Function and Preserve Renal Function
A study testing Pioglitazone and Nitroglycerin in people with Chronic Kidney Disease, run by Mayo Clinic at 1 site in United States.
Trial summary
The hypothesis of the current proposal is that chronic pioglitazone therapy will result in improved endothelial function, decreased inflammation, and preservation of renal function in patients with CKD but without diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Pioglitazone and Nitroglycerin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Jul 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age over 18 years.
- Creatinine clearance ≤ 60 ml/min by the Cockcroft-Gault equation
- Patients not anticipated to go on dialysis or have renal transplantation in the next 6 months
- Ability to provide informed consent
- Life expectancy greater than 12 months
Who cannot join
- Diabetes mellitus or a fasting blood glucose ≥ 110 mg/dL
- Acute renal failure
- Class 3 or 4 heart failure
- Liver failure, ascites, or an aspartate aminotransferase (AST) or alanine aminotransferase (ALT) two times the upper limit of normal
- Hemoglobin less than 9 mg/dL
- Multiple myeloma
Show all 10Show fewer
- Premenopausal women not using at least 1 form of birth control
- Pregnant or nursing women
- Prisoners
- Known allergy to pioglitazone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Chronic Thiazolidinedione Therapy Improve Endothelial Function and Preserve Renal Function in Non-Diabetic Patients With Chronic Kidney Disease?
The hypothesis of the current proposal is that chronic pioglitazone therapy will result in improved endothelial function, decreased inflammation, and preservation of renal function in patients with CKD but without diabetes.
Read the detailed description
Despite continued improvements in the outcomes of patients with cardiovascular disease, similar improvements have not been seen in patients with chronic kidney disease (CKD). CKD constitutes one of the highest risk populations for cardiovascular disease. When the creatinine clearance is ≤ 60 ml/min the risk for cardiovascular events is greater than that of diabetes. However, few studies have focused on the prevention or treatment of coronary artery disease (CAD) in CKD patients.
The development of endothelial dysfunction and increased inflammation appear to be critical in the development of atherosclerosis and cardiovascular disease. The broad long-term objective of this grant proposal is to determine unique therapies to reduce endothelial dysfunction and inflammation, and thereby help to prevent cardiovascular disease and preserve renal function in patients with CKD. Thiazolidinediones such as pioglitazone appear to improve endothelial function and decrease inflammation, an effect that may be present in patients with or without diabetes.
To address this hypothesis the following Specific Aims are proposed:
- To determine the effects of chronic pioglitazone therapy on endothelial function in non-diabetic patients with CKD (creatinine clearance ≤ 60 ml/ min, but not on dialysis)
- To determine the effects chronic pioglitazone therapy on inflammation and oxidative stress in non-diabetic patients with CKD
- To determine the effects chronic pioglitazone therapy on progression of renal disease in non-diabetic patients with CKD
- Conditions
- Chronic Kidney Disease
- Being tested
- Pioglitazone, Placebo, Nitroglycerin
- Keywords
- Kidney Failure, Chronic, Renal Insufficiency, Chronic, Proteinuria, Albuminuria
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic, Proteinuria, Albuminuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PioglitazoneDrug
Also called Actos
Pioglitazone 30 mg daily for 6 months
PlaceboDrug
Placebo 30 mg daily for 6 months
NitroglycerinDrug
Also called Nitrostat
0.4 mg sublingual nitroglycerin tablet was given to all patients without a contraindication to check the brachial reactivity.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo 30 mg daily for 6 months, nitroglycerin was given to check the brachial reactivity. Receives: Drug: Placebo; Drug: Nitroglycerin |
| Pioglitazone | Active comparator | Pioglitazone 30 mg daily for 6 months, nitroglycerin was given to check the brachial reactivity. Receives: Drug: Pioglitazone; Drug: Nitroglycerin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Brachial Arterial Reactivity
Brachial arterial reactivity was measured by ultrasound. A blood pressure cuff was placed around the right forearm. Using the ultrasound probe of the ultrasound, 2-dimensional images clearly defining the anterior and posterior intimal wall of the brachial artery were collected. Flow velocities were then measured using pulsed wave Doppler. The blood pressure cuff previously placed around the patient's right forearm was inflated to 200 mmHg. The cuff remained inflated for 5 minutes as the patient remained motionless and quiet. Prior to deflation, the patient was asked to remain still as flow velocities and 2-dimensional images were obtained immediately following cuff deflation. Then a 0.4 mg sublingual nitroglycerin tablet was given to all patients without a contraindication and all measurements were repeated.
Measured: After 6 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2008 (estimated)
- Study startMar 2006
- Primary completionJan 2009
- Study completionJul 2009
Why it stopped: Low enrollment because of the specifics of the inclusion criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia J M Best, Mayo Clinic
- Investigators
- Patricia M. Best, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00586261
- Sponsor's protocol ID
- 06-002245
- Status last verified
- Mar 2013
- First submitted
- 21 Dec 2007
- Last updated
- 15 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Chronic Thiazolidinedione Therapy Improve Endothelial Function and Preserve Renal Function in Non-Diabetic Patients With Chronic Kidney Disease?
- ClinicalTrials.gov ID
- NCT00586261
- Acronym / sponsor ID
- 06-002245
- Conditions
- Chronic Kidney Disease
- Keywords
- Kidney Failure, Chronic, Renal Insufficiency, Chronic, Proteinuria, Albuminuria
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment because of the specifics of the inclusion criteria
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 4 Jan 2008 (estimated)
- Results
- Posted 7 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypothesis of the current proposal is that chronic pioglitazone therapy will result in improved endothelial function, decreased inflammation, and preservation of renal function in patients with CKD but without diabetes.
Detailed description
Despite continued improvements in the outcomes of patients with cardiovascular disease, similar improvements have not been seen in patients with chronic kidney disease (CKD). CKD constitutes one of the highest risk populations for cardiovascular disease. When the creatinine clearance is ≤ 60 ml/min the risk for cardiovascular events is greater than that of diabetes. However, few studies have focused on the prevention or treatment of coronary artery disease (CAD) in CKD patients.
The development of endothelial dysfunction and increased inflammation appear to be critical in the development of atherosclerosis and cardiovascular disease. The broad long-term objective of this grant proposal is to determine unique therapies to reduce endothelial dysfunction and inflammation, and thereby help to prevent cardiovascular disease and preserve renal function in patients with CKD. Thiazolidinediones such as pioglitazone appear to improve endothelial function and decrease inflammation, an effect that may be present in patients with or without diabetes.
To address this hypothesis the following Specific Aims are proposed:
- To determine the effects of chronic pioglitazone therapy on endothelial function in non-diabetic patients with CKD (creatinine clearance ≤ 60 ml/ min, but not on dialysis)
- To determine the effects chronic pioglitazone therapy on inflammation and oxidative stress in non-diabetic patients with CKD
- To determine the effects chronic pioglitazone therapy on progression of renal disease in non-diabetic patients with CKD
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo, Drug: NitroglycerinPlacebo 30 mg daily for 6 months, nitroglycerin was given to check the brachial reactivity. |
| Pioglitazone | Active comparator | Drug: Pioglitazone, Drug: NitroglycerinPioglitazone 30 mg daily for 6 months, nitroglycerin was given to check the brachial reactivity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age over 18 years.
- Creatinine clearance ≤ 60 ml/min by the Cockcroft-Gault equation
- Patients not anticipated to go on dialysis or have renal transplantation in the next 6 months
- Ability to provide informed consent
- Life expectancy greater than 12 months
Key exclusion criteria (10 listed)
- Diabetes mellitus or a fasting blood glucose ≥ 110 mg/dL
- Acute renal failure
- Class 3 or 4 heart failure
- Liver failure, ascites, or an aspartate aminotransferase (AST) or alanine aminotransferase (ALT) two times the upper limit of normal
- Hemoglobin less than 9 mg/dL
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: ActosPioglitazone 30 mg daily for 6 months | Drug | Pioglitazone |
| PlaceboPlacebo 30 mg daily for 6 months | Drug | Placebo |
| NitroglycerinAlso: Nitrostat0.4 mg sublingual nitroglycerin tablet was given to all patients without a contraindication to check the brachial reactivity. | Drug | Pioglitazone, Placebo |
Primary outcome
Change in Brachial Arterial Reactivity
Time frame: After 6 months of treatment
Brachial arterial reactivity was measured by ultrasound. A blood pressure cuff was placed around the right forearm. Using the ultrasound probe of the ultrasound, 2-dimensional images clearly defining the anterior and posterior intimal wall of the brachial artery were collected. Flow velocities were then measured using pulsed wave Doppler. The blood pressure cuff previously placed around the patient's right forearm was inflated to 200 mmHg. The cuff remained inflated for 5 minutes as the patient remained motionless and quiet. Prior to deflation, the patient was asked to remain still as flow velocities and 2-dimensional images were obtained immediately following cuff deflation. Then a 0.4 mg sublingual nitroglycerin tablet was given to all patients without a contraindication and all measurements were repeated.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Patricia M. Best, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pioglitazone and Nitroglycerin in people with Chronic Kidney Disease, run by Mayo Clinic at 1 site in United States.
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 5 inclusion and 10 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: stopped early, as of the sponsor's last update on 15 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 7 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Brachial Arterial Reactivity (time frame: After 6 months of treatment). 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 15 Mar 2013.