Kidney DiseaseNCT01228903
Uric Acid and the Endothelium in CKD
A study testing Allopurinol in people with Kidney Disease, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study will test the hypothesis that uric acid impairs the function of vessels in patients with kidney disease Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Disease
- 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
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Sep 2016
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with moderate chronic kidney disease (CKD stage III) with estimated glomerular filtration rates between 30-60 mL/min/ 1.73m2
- Elevated uric acid levels
- Age range: more than 18 years old
- Ability to give informed consent
- Albumin > 3.0 g/dL
- BMI < 40 kg/m2
Who cannot join
- Life expectancy < 1.0 years
- Expected to undergo living related kidney transplant in 6 months
- Pregnant, breast feeding, or unwilling to use adequate birth control
- History of severe liver disease
- History of severe congestive heart failure
- History of hospitalizations within 3 months
Show all 12Show fewer
- Active infection, on antibiotics
- History of Warfarin Use or other medications that are contraindicated with allopurinol
- Uncontrolled hypertension
- History of acute gout on Allopurinol
- History of adverse reaction to Allopurinol
- Immunosuppressive therapy within the last 1 yr
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado at Denver
Aurora, Colorado, 80045
About this study
Official title: Is Uric Acid a Mediator of Endothelial Dysfunction in Patients With Chronic Kidney Disease?
This study will test the hypothesis that uric acid impairs the function of vessels in patients with kidney disease
Read the detailed description
The purpose of the study is to understand the effect of lowering serum uric acid levels on vascular function in individuals with chronic kidney disease by comparing the effects of:
- Allopurinol therapy and 2) Placebo.
Patients will receive: 3 month study drug (either allopurinol or placebo), with assessment of serum uric acid levels and vascular function.
- Conditions
- Kidney Disease
- Being tested
- Allopurinol, Placebo
- Keywords
- uric acid kidney disease endothelial dysfunction
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AllopurinolDrug
Also called Zyloprim, Allohexal, Allosig, Milurit, Alloril, Progout, Zyloric.
Xanthine oxidase inhibitor- effective at lowering uric acid levels.
PlaceboOther
Placebo tablets with no active ingredient
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Patients who are randomized to this group will received placebo tablets. Placebo tables do not contain an active ingredient. This group will be used as a baseline group to compare the effects of lowering uric acid on vascular function. Receives: Other: Placebo |
| Allopurinol | Active comparator | Patients who are randomized to this group will receive allopurinol tablets. Allopurinol is a medicine that lowers uric acid levels. The effects of lowering uric acid on vascular function outcomes will be assessed and compared to the control group. Receives: Drug: Allopurinol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Endothelial Dependent Dilation From Baseline to Week 12
Change in Endothelial Dependent Dilation measured by Flow Mediated Dilation at baseline and week 12
Measured: Baseline and 12 weeks
Secondary outcomes (4)
Change in C-reactive Protein From Baseline to Week 12
Measured: Baseline and 12 weeks
Change in Serum Interleukin-6 From Baseline to Week 12
Measured: Baseline and 12 weeks
Change in Monocyte Chemotactic Protein-1 From Baseline to Week 12
Measured: Baseline and 12 weeks
Change in Oxidized Low Density Lipoprotein From Baseline to Week 12
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionSep 2016
- Study completionSep 2016
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Diana Jalal, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01228903
- Sponsor's protocol ID
- 10-0625
- Other IDs
- K23DK088833
- Status last verified
- May 2017
- First submitted
- 25 Oct 2010
- Last updated
- 28 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: De-identified data will be made available to investigators upon request from the PI
Publications
Perrenoud L, Kruse NT, Andrews E, You Z, Chonchol M, Wu C, Ten Eyck P, Zepeda-Orozco D, Jalal D. Uric Acid Lowering and Biomarkers of Kidney Damage in CKD Stage 3: A Post Hoc Analysis of a Randomized Clinical Trial. Kidney Med. 2020 Feb 26;2(2):155-161. doi: 10.1016/j.xkme.2019.11.007. eCollection 2020 Mar-Apr.
PubMed 32964203
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Uric Acid a Mediator of Endothelial Dysfunction in Patients With Chronic Kidney Disease?
- ClinicalTrials.gov ID
- NCT01228903
- Acronym / sponsor ID
- 10-0625
- Conditions
- Kidney Disease
- Keywords
- uric acid kidney disease endothelial dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Oct 2010
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 27 Oct 2010 (estimated)
- Results
- Posted 23 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test the hypothesis that uric acid impairs the function of vessels in patients with kidney disease
Detailed description
The purpose of the study is to understand the effect of lowering serum uric acid levels on vascular function in individuals with chronic kidney disease by comparing the effects of:
- Allopurinol therapy and 2) Placebo.
Patients will receive: 3 month study drug (either allopurinol or placebo), with assessment of serum uric acid levels and vascular function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: PlaceboPatients who are randomized to this group will received placebo tablets. Placebo tables do not contain an active ingredient. This group will be used as a baseline group to compare the effects of lowering uric acid on vascular function. |
| Allopurinol | Active comparator | Drug: AllopurinolPatients who are randomized to this group will receive allopurinol tablets. Allopurinol is a medicine that lowers uric acid levels. The effects of lowering uric acid on vascular function outcomes will be assessed and compared to the control group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Individuals with moderate chronic kidney disease (CKD stage III) with estimated glomerular filtration rates between 30-60 mL/min/ 1.73m2
- Elevated uric acid levels
- Age range: more than 18 years old
- Ability to give informed consent
- Albumin > 3.0 g/dL
Key exclusion criteria (12 listed)
- Life expectancy < 1.0 years
- Expected to undergo living related kidney transplant in 6 months
- Pregnant, breast feeding, or unwilling to use adequate birth control
- History of severe liver disease
- History of severe congestive heart failure
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 |
|---|---|---|
| AllopurinolAlso: Zyloprim, Allohexal, Allosig, Milurit, Alloril, Progout, Zyloric.Xanthine oxidase inhibitor- effective at lowering uric acid levels. | Drug | Allopurinol |
| PlaceboPlacebo tablets with no active ingredient | Other | Control |
Primary outcome
Change in Endothelial Dependent Dilation From Baseline to Week 12
Time frame: Baseline and 12 weeks
Change in Endothelial Dependent Dilation measured by Flow Mediated Dilation at baseline and week 12
4 secondary outcomes
Change in C-reactive Protein From Baseline to Week 12
Time frame: Baseline and 12 weeks
Change in Serum Interleukin-6 From Baseline to Week 12
Time frame: Baseline and 12 weeks
Change in Monocyte Chemotactic Protein-1 From Baseline to Week 12
Time frame: Baseline and 12 weeks
Change in Oxidized Low Density Lipoprotein From Baseline to Week 12
Time frame: Baseline and 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32964203Perrenoud L, Kruse NT, Andrews E, You Z, Chonchol M, Wu C, Ten Eyck P, Zepeda-Orozco D, Jalal D. Uric Acid Lowering and Biomarkers of Kidney Damage in CKD Stage 3: A Post Hoc Analysis of a Randomized Clinical Trial. Kidney Med. 2020 Feb 26;2(2):155-161. doi: 10.1016/j.xkme.2019.11.007. eCollection 2020 Mar-Apr.
- Information about the Recruiting CenterLink provided by the sponsor.
- What is the endothelium?Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified data will be made available to investigators upon request from the PI
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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.
Diana Jalal, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Allopurinol in people with Kidney Disease, run by University of Colorado, Denver 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 6 inclusion and 12 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 28 Jun 2017. 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 23 Feb 2017). 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 Endothelial Dependent Dilation From Baseline to Week 12 (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01228903, which also lists 1 linked publication.
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 28 Jun 2017.