GoutPhase 4NCT02579096
CSP594 Comparative Effectiveness in Gout: Allopurinol vs. Febuxostat
A Phase 4 study testing allopurinol capsule, 100-800 mg by mouth once daily and febuxostat tablet 40-120 mg by mouth once daily in people with Gout and Chronic Kidney Diseases, run by VA Office of Research and Development at 23 sites in United States.
Trial summary
This trial will compare two effective therapies, allopurinol and febuxostat, to lower serum uric acid and therefore prevent further gout attacks. These therapies have never been compared at appropriate doses. Further, they will be studied in patients with kidney disease for the first time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gout, Chronic Kidney Diseases
- What is being tested?
- allopurinol capsule, 100-800 mg by mouth once daily and febuxostat tablet 40-120 mg by mouth once daily
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 950 participants
- Where
- 23 sitesUnited States
- Study dates
- 6 Mar 2017to 15 Apr 2021
- Phase
- Phase 4
- 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 18 years
- History of gout - crystal proven or historical as defined by ACR criteria listed above
- Serum urate level > 6.8 mg/dl
Who cannot join
- Stage 4 or 5 Chronic Kidney Disease (CKD) - defined as eGFR < 30 ml/min/1.73 m2
- Women less than 50 years of age
- Patients with a history of prior solid organ / hematopoietic transplantation
- Previous allergy or intolerance to allopurinol or febuxostat
- Patients who are not candidates for any of the recommended prophylactic medications (colchicine, naprosyn or glucocorticoids)
- Patients who in the opinion of the investigator have a high genetic risk for allopurinol hypersensitivity syndrome (AHS*) unless they have been found to be negative for HLA B5801.
Show all 20Show fewer
- Previous history of failure to reach target uric acid levels despite therapy with allopurinol at dose > 300 mg/day
- Prior febuxostat use
- Patients with malignancies that are currently active with exception of non-melanoma skin cancer
- Patients with serum uric acid levels >15 mg/dl
- Patients with myelodysplasia and hemoglobin of < 8.5 mg/dL
- Patients with chronic liver disease with more than one of the following:
- INR > 1.7, not on Warfarin therapy
- Bilirubin 2 mg/dL
- Serum albumin < 3.5 mg/dL
- Ascites
- Encephalopathy
- Current use of azathioprine, mercaptopurine, didanosine, cyclophosphamide, probenecid, lesinurad or pegloticase
- Enrollment in another randomized interventional clinical trial
- Any severe medical condition that, in the enrolleer's opinion, is likely to compromise the participant's ability to complete the trial
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Asheville VA Medical Center, Asheville, NC
Asheville, North Carolina, 28805
Sanford Bismarck Medical Center ? RAIN 2
Bismarck, North Dakota, 58506
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130
Cincinnati VA Medical Center, Cincinnati, OH
Cincinnati, Ohio, 45220
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, 75216
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, 60141-5000
Kansas City VA Medical Center, Kansas City, MO
Kansas City, Missouri, 64128
VA Loma Linda Healthcare System, Loma Linda, CA
Loma Linda, California, 92357
Miami VA Healthcare System, Miami, FL
Miami, Florida, 33125
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
New York, New York, 10010
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
Omaha, Nebraska, 68105-1850
University of Nebraska Medical Center ? RAIN 5
Omaha, Nebraska, 68198-3025
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, 19104
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97239
Mayo Clinic Rochester MN ? RAIN 1
Rochester, Minnesota, 55905
Salem VA Medical Center, Salem, VA
Salem, Virginia, 24153
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, 84148
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, 94121
White River Junction VA Medical Center, White River Junction, VT
White River Junction, Vermont, 05009-0001
Yankton Medical Clinic ? RAIN 3
Yankton, South Dakota, 57078
About this study
Official title: CSP #594 - Comparative Effectiveness in Gout: Allopurinol vs. Febuxostat
This trial will compare two effective therapies, allopurinol and febuxostat, to lower serum uric acid and therefore prevent further gout attacks. These therapies have never been compared at appropriate doses. Further, they will be studied in patients with kidney disease for the first time.
Read the detailed description
Gout is the most common form of inflammatory arthritis affecting adults (1), with a disease frequency that continues to increase dramatically (2). Gout is associated with substantial morbidity and mortality which are concentrated in older men and magnified in patients with chronic kidney disease (CKD) (3-6), demographics common to the Veterans Affairs (VA) Health System. Effective gout therapies are readily available and are centered primarily on the use of approved urate lowering therapy (ULT). Despite having excellent ULT options available to patients (7), gout is extremely poorly managed especially in patients with CKD (8-10).
The two most widely used ULTs in clinical practice, allopurinol and febuxostat, have recently been endorsed as the two acceptable first-line treatment strategies in chronic gout (7). Although both agents appear to be efficacious and generally well-tolerated, allopurinol and febuxostat have significantly different costs and have never been compared to each other at appropriate doses. Randomized controlled trials completed to date comparing allopurinol with febuxostat in gout have used 'fixed' and, in many cases, insufficient doses of allopurinol (11-13), an approach that is contrary to current guideline recommendations (7). Furthermore, these studies have included only very small proportions of gout patients with CKD even though CKD is present in approximately 1 of every 2 gout sufferers (14).
To test the hypothesis that allopurinol is non-inferior to febuxostat in the treatment of gout, the investigators propose a randomized open-label non-inferiority trial, which for the first time compares allopurinol with febuxostat using appropriately titrated doses and a "treat-to-target" approach. Further, the investigators will assess the comparative effectiveness of these agents in a significant number of gout patients with co-morbid CKD.
The investigators plan to enroll 950 participants with a diagnosis of gout, including participants with stage 3 CKD, who are hyperuricemic defined as a serum uric acid concentration (sUA) above 6.8 mg/dl. Participants will be recruited from 18 Veteran Affairs and 5 Rheumatology and Arthritis Investigational Network (RAIN) sites. The total duration of the trial will be 4 years. Recruitment will occur over 24 months. Participants will be followed for 72 weeks. This will include a 24 week Dose Titration Phase (Phase 1) followed by a 24 week Maintenance and Optimization Phase (Phase 2) and then a 24 week Steady State Flare Observation Phase (Phase 3). The investigators will use a "treat-to-target" approach with specified titration of ULT dosing to obtain goal sUA. Maximal daily drug doses will be 800 mg/day for allopurinol or 120 mg/day for febuxostat.
The primary outcome will be the proportion of participants who have at least one gout flare in the allopurinol group compared to the febuxostat group during Phase 3. This primary outcome was endorsed by the patient and VA provider groups that were surveyed (see below). All participants will be followed during Phase 3 regardless of the achievement of sUA goal. The primary hypothesis will test the non-inferiority of allopurinol with regards to proportions of flares. The investigators anticipate that approximately 15 to 20% of patients will flare during Phase 3.
- Conditions
- Gout, Chronic Kidney Diseases
- Being tested
- allopurinol capsule, 100-800 mg by mouth once daily, febuxostat tablet 40-120 mg by mouth once daily, Placebo, vehicle control (febuxostat-shaped), Placebo, vehicle control (allopurinol-shaped)
- Keywords
- Gout, Allopurinol, Febuxostat, CKD
- Medical subject headings
- Gout, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allopurinol capsule, 100-800 mg by mouth once dailyDrug
Also called Zyloprim; CAS: 315-30-0
Patients will be up-titrated up to the dose required to reach target uric acid levels.
febuxostat tablet 40-120 mg by mouth once dailyDrug
Also called Uloric; CAS: 144060-53-7; NDCs: 64764-677-11, 64764-677-13, 64764-677-19, 64764-677-30, 64764-918-11, 64764-918-18, 64764-918-30, 64764-918-90
Patients will be up-titrated to the dose required to reach target uric acid levels.
Placebo, vehicle control (febuxostat-shaped)Drug
Placebo tablets resembling febuxostat will be given with allopurinol.
Placebo, vehicle control (allopurinol-shaped)Drug
Placebo capsules resembling allopurinol will be given with febuxostat.
| Study group | Role | What they receive |
|---|---|---|
| Allopurinol / Sham Comparator (Febuxostat) | Active comparator | Patients will be titrated up to the dose that will lower to target uric acid levels. A placebo resembling Febuxostat will be given with allopurinol Receives: Drug: allopurinol capsule, 100-800 mg by mouth once daily; Drug: Placebo, vehicle control (febuxostat-shaped) |
| Febuxostat / Sham Comparator (Allopurinol) | Active comparator | Febuxostat will be titrated up to the dose that will lower to target uric acid levels. A placebo resembling Allopurinol will be given with Febuxostat Receives: Drug: febuxostat tablet 40-120 mg by mouth once daily; Drug: Placebo, vehicle control (allopurinol-shaped) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Experiencing ≥ 1 Gout Flare During Phase 3
Participants were defined as flaring in Phase 3 if they:
-1) met 3 of 4 following participant-reported criteria:
- a) warm joint(s)
- b) swollen joint(s)
- c) pain (>3) at rest on a scale of 0-10 (10 being the worst pain)
- d) self-identified gout flare
OR
-2) reported use of medications to treat flare
Measured: Phase III of the study (weeks 49-72 of study duration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study start6 Mar 2017
- Primary completion1 Feb 2021
- Study completion15 Apr 2021
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 (6)Papers the sponsor has linked to this study.
- Other trials for GoutStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 950 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- James R O'Dell, Study chair, Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02579096
- Sponsor's protocol ID
- 594
- Status last verified
- Mar 2024
- First submitted
- 15 Oct 2015
- Last updated
- 29 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual Participant Data will be made available after study closure only to research credentialed Veterans Affairs researchers who submit a valid study question to their IRB of record. A Data Use Agreement will be in effect between the researcher and the coordinating center
Publications
Timilsina S, Brittan K, O'Dell JR, Brophy M, Davis-Karim A, Henrie AM, Neogi T, Newcomb J, Palevsky PM, Pillinger MH, Pittman D, Taylor TH, Wu H, Mikuls TR. Design and Rationale for the Veterans Affairs "Cooperative Study Program 594 Comparative Effectiveness in Gout: Allopurinol vs. Febuxostat" Trial. Contemp Clin Trials. 2018 May;68:102-108. doi: 10.1016/j.cct.2018.03.015. Epub 2018 Mar 27.
PubMed 29597007O'Dell JR, Brophy MT, Pillinger MH, Neogi T, Palevsky PM, Wu H, Davis-Karim A, Newcomb JA, Ferguson R, Pittman D, Cannon GW, Taylor T, Terkeltaub R, Cannella AC, England BR, Helget LN, Mikuls TR. Comparative Effectiveness of Allopurinol and Febuxostat in Gout Management. NEJM Evid. 2022 Mar;1(3):10.1056/evidoa2100028. doi: 10.1056/evidoa2100028. Epub 2022 Feb 3.
PubMed 35434725Sanchez C, Campeau A, Liu-Bryan R, Mikuls TR, O'Dell JR, Gonzalez DJ, Terkeltaub R. Effective xanthine oxidase inhibitor urate lowering therapy in gout is linked to an emergent serum protein interactome of complement and inflammation modulators. Sci Rep. 2024 Oct 19;14(1):24598. doi: 10.1038/s41598-024-74154-5.
PubMed 39426967Sanchez C, Campeau A, Liu-Bryan R, Mikuls TR, O'Dell JR, Gonzalez DJ, Terkeltaub R. Effective xanthine oxidase inhibitor urate lowering therapy in gout is linked to an emergent serum protein interactome of complement activation and inflammation modulators. Res Sq [Preprint]. 2024 May 9:rs.3.rs-4278877. doi: 10.21203/rs.3.rs-4278877/v1.
PubMed 38766125Sanchez C, Campeau A, Liu-Bryan R, Mikuls T, O'Dell J, Gonzalez D, Terkeltaub R. Sustained xanthine oxidase inhibitor treat to target urate lowering therapy rewires a tight inflammation serum protein interactome. Res Sq [Preprint]. 2024 Jan 2:rs.3.rs-3770277. doi: 10.21203/rs.3.rs-3770277/v1.
PubMed 38260556Helget LN, O'Dell JR, Newcomb JA, Androsenko M, Brophy MT, Davis-Karim A, England BR, Ferguson R, Pillinger MH, Neogi T, Palevsky PM, Wu H, Kramer B, Mikuls TR. Determinants of Achieving Serum Urate Goal with Treat-to-Target Urate-Lowering Therapy in Gout. Arthritis Rheumatol. 2024 Apr;76(4):638-646. doi: 10.1002/art.42731. Epub 2023 Dec 26.
PubMed 37842953
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSP #594 - Comparative Effectiveness in Gout: Allopurinol vs. Febuxostat
- ClinicalTrials.gov ID
- NCT02579096
- Acronym / sponsor ID
- 594
- Conditions
- Gout, Chronic Kidney Diseases
- Keywords
- Gout, Allopurinol, Febuxostat, CKD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 950 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 19 Oct 2015 (estimated)
- Results
- Posted 11 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial will compare two effective therapies, allopurinol and febuxostat, to lower serum uric acid and therefore prevent further gout attacks. These therapies have never been compared at appropriate doses. Further, they will be studied in patients with kidney disease for the first time.
Detailed description
Gout is the most common form of inflammatory arthritis affecting adults (1), with a disease frequency that continues to increase dramatically (2). Gout is associated with substantial morbidity and mortality which are concentrated in older men and magnified in patients with chronic kidney disease (CKD) (3-6), demographics common to the Veterans Affairs (VA) Health System. Effective gout therapies are readily available and are centered primarily on the use of approved urate lowering therapy (ULT). Despite having excellent ULT options available to patients (7), gout is extremely poorly managed especially in patients with CKD (8-10).
The two most widely used ULTs in clinical practice, allopurinol and febuxostat, have recently been endorsed as the two acceptable first-line treatment strategies in chronic gout (7). Although both agents appear to be efficacious and generally well-tolerated, allopurinol and febuxostat have significantly different costs and have never been compared to each other at appropriate doses. Randomized controlled trials completed to date comparing allopurinol with febuxostat in gout have used 'fixed' and, in many cases, insufficient doses of allopurinol (11-13), an approach that is contrary to current guideline recommendations (7). Furthermore, these studies have included only very small proportions of gout patients with CKD even though CKD is present in approximately 1 of every 2 gout sufferers (14).
To test the hypothesis that allopurinol is non-inferior to febuxostat in the treatment of gout, the investigators propose a randomized open-label non-inferiority trial, which for the first time compares allopurinol with febuxostat using appropriately titrated doses and a "treat-to-target" approach. Further, the investigators will assess the comparative effectiveness of these agents in a significant number of gout patients with co-morbid CKD.
The investigators plan to enroll 950 participants with a diagnosis of gout, including participants with stage 3 CKD, who are hyperuricemic defined as a serum uric acid concentration (sUA) above 6.8 mg/dl. Participants will be recruited from 18 Veteran Affairs and 5 Rheumatology and Arthritis Investigational Network (RAIN) sites. The total duration of the trial will be 4 years. Recruitment will occur over 24 months. Participants will be followed for 72 weeks. This will include a 24 week Dose Titration Phase (Phase 1) followed by a 24 week Maintenance and Optimization Phase (Phase 2) and then a 24 week Steady State Flare Observation Phase (Phase 3). The investigators will use a "treat-to-target" approach with specified titration of ULT dosing to obtain goal sUA. Maximal daily drug doses will be 800 mg/day for allopurinol or 120 mg/day for febuxostat.
The primary outcome will be the proportion of participants who have at least one gout flare in the allopurinol group compared to the febuxostat group during Phase 3. This primary outcome was endorsed by the patient and VA provider groups that were surveyed (see below). All participants will be followed during Phase 3 regardless of the achievement of sUA goal. The primary hypothesis will test the non-inferiority of allopurinol with regards to proportions of flares. The investigators anticipate that approximately 15 to 20% of patients will flare during Phase 3.
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 |
|---|---|---|
| Allopurinol / Sham Comparator (Febuxostat) | Active comparator | Drug: allopurinol capsule, 100-800 mg by mouth once daily, Drug: Placebo, vehicle control (febuxostat-shaped)Patients will be titrated up to the dose that will lower to target uric acid levels. A placebo resembling Febuxostat will be given with allopurinol |
| Febuxostat / Sham Comparator (Allopurinol) | Active comparator | Drug: febuxostat tablet 40-120 mg by mouth once daily, Drug: Placebo, vehicle control (allopurinol-shaped)Febuxostat will be titrated up to the dose that will lower to target uric acid levels. A placebo resembling Allopurinol will be given with Febuxostat |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years
- History of gout - crystal proven or historical as defined by ACR criteria listed above
- Serum urate level > 6.8 mg/dl
Key exclusion criteria (20 listed)
- Stage 4 or 5 Chronic Kidney Disease (CKD) - defined as eGFR < 30 ml/min/1.73 m2
- Women less than 50 years of age
- Patients with a history of prior solid organ / hematopoietic transplantation
- Previous allergy or intolerance to allopurinol or febuxostat
- Patients who are not candidates for any of the recommended prophylactic medications (colchicine, naprosyn or glucocorticoids)
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 |
|---|---|---|
| allopurinol capsule, 100-800 mg by mouth once dailyAlso: Zyloprim; CAS: 315-30-0Patients will be up-titrated up to the dose required to reach target uric acid levels. | Drug | Allopurinol / Sham Comparator (Febuxostat) |
| febuxostat tablet 40-120 mg by mouth once dailyAlso: Uloric; CAS: 144060-53-7; NDCs: 64764-677-11, 64764-677-13, 64764-677-19, 64764-677-30, 64764-918-11, 64764-918-18, 64764-918-30, 64764-918-90Patients will be up-titrated to the dose required to reach target uric acid levels. | Drug | Febuxostat / Sham Comparator (Allopurinol) |
| Placebo, vehicle control (febuxostat-shaped)Placebo tablets resembling febuxostat will be given with allopurinol. | Drug | Allopurinol / Sham Comparator (Febuxostat) |
| Placebo, vehicle control (allopurinol-shaped)Placebo capsules resembling allopurinol will be given with febuxostat. | Drug | Febuxostat / Sham Comparator (Allopurinol) |
Primary outcome
Percentage of Participants Experiencing ≥ 1 Gout Flare During Phase 3
Time frame: Phase III of the study (weeks 49-72 of study duration)
Participants were defined as flaring in Phase 3 if they: -1) met 3 of 4 following participant-reported criteria: * a) warm joint(s) * b) swollen joint(s) * c) pain (>3) at rest on a scale of 0-10 (10 being the worst pain) * d) self-identified gout flare OR -2) reported use of medications to treat flare
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29597007Timilsina S, Brittan K, O'Dell JR, Brophy M, Davis-Karim A, Henrie AM, Neogi T, Newcomb J, Palevsky PM, Pillinger MH, Pittman D, Taylor TH, Wu H, Mikuls TR. Design and Rationale for the Veterans Affairs "Cooperative Study Program 594 Comparative Effectiveness in Gout: Allopurinol vs. Febuxostat" Trial. Contemp Clin Trials. 2018 May;68:102-108. doi: 10.1016/j.cct.2018.03.015. Epub 2018 Mar 27.
- Results publication: PubMed 35434725O'Dell JR, Brophy MT, Pillinger MH, Neogi T, Palevsky PM, Wu H, Davis-Karim A, Newcomb JA, Ferguson R, Pittman D, Cannon GW, Taylor T, Terkeltaub R, Cannella AC, England BR, Helget LN, Mikuls TR. Comparative Effectiveness of Allopurinol and Febuxostat in Gout Management. NEJM Evid. 2022 Mar;1(3):10.1056/evidoa2100028. doi: 10.1056/evidoa2100028. Epub 2022 Feb 3.
- Derived from this study: PubMed 39426967Sanchez C, Campeau A, Liu-Bryan R, Mikuls TR, O'Dell JR, Gonzalez DJ, Terkeltaub R. Effective xanthine oxidase inhibitor urate lowering therapy in gout is linked to an emergent serum protein interactome of complement and inflammation modulators. Sci Rep. 2024 Oct 19;14(1):24598. doi: 10.1038/s41598-024-74154-5.
- Derived from this study: PubMed 38766125Sanchez C, Campeau A, Liu-Bryan R, Mikuls TR, O'Dell JR, Gonzalez DJ, Terkeltaub R. Effective xanthine oxidase inhibitor urate lowering therapy in gout is linked to an emergent serum protein interactome of complement activation and inflammation modulators. Res Sq [Preprint]. 2024 May 9:rs.3.rs-4278877. doi: 10.21203/rs.3.rs-4278877/v1.
- Derived from this study: PubMed 38260556Sanchez C, Campeau A, Liu-Bryan R, Mikuls T, O'Dell J, Gonzalez D, Terkeltaub R. Sustained xanthine oxidase inhibitor treat to target urate lowering therapy rewires a tight inflammation serum protein interactome. Res Sq [Preprint]. 2024 Jan 2:rs.3.rs-3770277. doi: 10.21203/rs.3.rs-3770277/v1.
- Derived from this study: PubMed 37842953Helget LN, O'Dell JR, Newcomb JA, Androsenko M, Brophy MT, Davis-Karim A, England BR, Ferguson R, Pillinger MH, Neogi T, Palevsky PM, Wu H, Kramer B, Mikuls TR. Determinants of Achieving Serum Urate Goal with Treat-to-Target Urate-Lowering Therapy in Gout. Arthritis Rheumatol. 2024 Apr;76(4):638-646. doi: 10.1002/art.42731. Epub 2023 Dec 26.
- Individual participant dataSharing planned: Yes. Individual Participant Data will be made available after study closure only to research credentialed Veterans Affairs researchers who submit a valid study question to their IRB of record. A Data Use Agreement will be in effect between the researcher and the coordinating center
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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.
James R O'Dell study chair
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
23 sites 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 capsule, 100-800 mg by mouth once daily and febuxostat tablet 40-120 mg by mouth once daily in people with Gout and Chronic Kidney Diseases, run by VA Office of Research and Development at 23 sites 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 3 inclusion and 20 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 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites 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. 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?
Yes. Results are posted in the registry (first posted 11 Jan 2022). 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?
Percentage of Participants Experiencing ≥ 1 Gout Flare During Phase 3 (time frame: Phase III of the study (weeks 49-72 of study duration)). 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 NCT02579096, which also lists 6 linked publications.
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 29 Mar 2024.