Kidney DiseasePhase 4NCT00688480
Do Xanthine Oxidase Inhibitors Reduce Both Left Ventricular Hypertrophy and Endothelial Dysfunction in Cardiovascular Patients With Renal Dysfunction?
A Phase 4 study testing Allopurinol in people with Kidney Disease and Left Ventricular Hypertrophy, run by A. D. Struthers at 1 site in United Kingdom.
Trial summary
Cardiovascular related disease is the main cause of death in patients with kidney disease, and "oxidative stress" is thought to be a major contributor by promoting thickening of the heart muscle and stiffening of the arteries. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kidney Disease, Left Ventricular Hypertrophy
- What is being tested?
- Allopurinol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2008to Feb 2010
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- CKD stage 3
- Echo LVH
Who cannot join
- Known heart failure
- Patients already on Allopurinol
- Patients with gout
- Patients with hepatic disease
- Contraindications to MRI, including severe claustrophobia
- Current immunosuppressive therapy, chlorpropamide, theophylline, 6- mercaptopurine
Show all 9Show fewer
- Malignancy or other life threatening disease
- Pregnancy or lactating women
- Patients unable to provide written consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Division of Medicine and Therapeutics, Ninewells Hospital & Medical School
Dundee, DD1 9SY
About this study
Cardiovascular related disease is the main cause of death in patients with kidney disease, and "oxidative stress" is thought to be a major contributor by promoting thickening of the heart muscle and stiffening of the arteries. Allopurinol, a drug used safely in the treatment of gout for many years, has been found to dramatically reduce "oxidative stress". It is therefore hoped that it also reduce the thickened heart muscle and stiffened arteries. If it did, it is likely to reduce the appallingly high cardiac death rate in this group of kidney disease patients.
- Conditions
- Kidney Disease, Left Ventricular Hypertrophy
- Being tested
- Placebo, Allopurinol
- Keywords
- CKD, LVH, Echo LVH, Chronic Stage 3
- Medical subject headings
- Kidney Diseases, Hypertrophy, Left Ventricular, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
1 capsule, orally for 9 months
AllopurinolDrug
Allopurinol 300 mg once/day orally, 9 months
| Study group | Role | What they receive |
|---|---|---|
| I | Placebo comparator | CKD Stage 3 (estimated GFR 30 - 60 ml/min/1.73m2), Echo LVH Receives: Drug: Placebo |
| 2 | Active comparator | Not described Receives: Drug: Allopurinol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary objective is to see if Allopurinol reduces left ventricular hypertrophy (LVH) in this group of CKD patients
Measured: 9 months
Secondary outcomes (1)
Secondary objective is to see if Allopurinol reduces endothelial dysfunction in this group of CKD patients
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2008 (estimated)
- Study startJan 2008
- Primary completionAug 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- A. D. Struthers
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, A. D. Struthers, University of Dundee
- Investigators
- Allan D Struthers, BSc, MD, FRCP, FESC, Principal investigator, University of Dundee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00688480
- Sponsor's protocol ID
- MK001
- Status last verified
- Nov 2016
- First submitted
- 29 May 2008
- Last updated
- 3 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Xanthine Oxidase Inhibitors Reduce Both Left Ventricular Hypertrophy and Endothelial Dysfunction in Cardiovascular Patients With Renal Dysfunction?
- ClinicalTrials.gov ID
- NCT00688480
- Acronym / sponsor ID
- MK001
- Conditions
- Kidney Disease, Left Ventricular Hypertrophy
- Keywords
- CKD, LVH, Echo LVH, Chronic Stage 3
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- A. D. StruthersUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 3 Jun 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.
Cardiovascular related disease is the main cause of death in patients with kidney disease, and "oxidative stress" is thought to be a major contributor by promoting thickening of the heart muscle and stiffening of the arteries. Allopurinol, a drug used safely in the treatment of gout for many years, has been found to dramatically reduce "oxidative stress". It is therefore hoped that it also reduce the thickened heart muscle and stiffened arteries. If it did, it is likely to reduce the appallingly high cardiac death rate in this group of kidney disease patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Placebo comparator | Drug: PlaceboCKD Stage 3 (estimated GFR 30 - 60 ml/min/1.73m2), Echo LVH |
| 2 | Active comparator | Drug: Allopurinol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- CKD stage 3
- Echo LVH
Key exclusion criteria (9 listed)
- Known heart failure
- Patients already on Allopurinol
- Patients with gout
- Patients with hepatic disease
- Contraindications to MRI, including severe claustrophobia
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 |
|---|---|---|
| Placebo1 capsule, orally for 9 months | Drug | I |
| AllopurinolAllopurinol 300 mg once/day orally, 9 months | Drug | 2 |
Primary outcome
Primary objective is to see if Allopurinol reduces left ventricular hypertrophy (LVH) in this group of CKD patients
Time frame: 9 months
1 secondary outcome
Secondary objective is to see if Allopurinol reduces endothelial dysfunction in this group of CKD patients
Time frame: 9 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 3 Nov 2016.
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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.
Allan D Struthers, BSc, MD, FRCP, FESC principal investigator
University of Dundee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Allopurinol in people with Kidney Disease and Left Ventricular Hypertrophy, run by A. D. Struthers at 1 site in United Kingdom.
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 9 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 3 Nov 2016. 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 Kingdom. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 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?
Primary objective is to see if Allopurinol reduces left ventricular hypertrophy (LVH) in this group of CKD patients (time frame: 9 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 3 Nov 2016.