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GoutPhase 4NCT03226899

A Phase 4 Safety and Efficacy Study to Evaluate Lesinurad 200 mg in Participants With Gout and Renal Impairment

A Phase 4 study testing Lesinurad, XOI and colchicine in people with Gout and Chronic Kidney Disease (CKD), run by Ironwood Pharmaceuticals, Inc. at 116 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This study evaluates the safety and efficacy of lesinurad administered with an XOI versus a placebo plus an XOI in gout participants who have moderate renal impairment and who are not at target level of serum urate (sUA). Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Gout, Chronic Kidney Disease (CKD)
What is being tested?
Lesinurad, XOI and colchicine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
242 participants
Where
116 sitesin 4 countries
Study dates
19 Jul 2017to 25 Feb 2019
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 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject is able to understand the study procedures, the risks involved, and willing to provide written informed consent before the first study related activity.
  • Subject is willing to adhere to the protocol schedule.
  • Subject is ≥ 18 years and ≤ 85 years of age.
  • Subject has a diagnosis of gout.
  • Subject has moderate renal impairment with estimated creatinine clearance (eCrCl; calculated by the Cockcroft-Gault formula using ideal body weight) 25.0 to ≤ 65.0 mL/min at Screening Visits 1 and 2 and an average eCrCl for both screening visits of 30.0 to < 60.0 mL/min.
  • Subject has been taking an XOI as ULT indicated for the treatment of gout for at least 4 weeks prior to Screening at a stable, medically appropriate dose, as determined by the Investigator. The minimum dose of allopurinol is 200 mg daily, and the minimum dose of febuxostat is the lowest approved dose per the local product label.
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  • Subject has a serum uric acid level ≥ 6.0 mg/dL (357 µmol/L) at Screening Visits 1 and 2.
  • Subject is male or female; females must not be pregnant or breastfeeding and females of childbearing potential must agree to use nonhormonal contraception during the Screening Period and while taking investigation product (IP).
  • Subject has a body mass index < 45 kg/m^2.

Who cannot join

  • Subject had unstable angina, New York Heart Association class III or IV heart failure, myocardial infarction, or stroke within the last 6 months prior to randomization; or had a deep venous thrombosis within the previous 3 months prior to randomization.
  • Subject has uncontrolled hypertension (defined as systolic pressure above 160 or diastolic pressure above 95 mm Hg at either Screening Visits 1 or 2).
  • Subject has severe hepatic impairment (defined as Child-Pugh Class C) or is known human immunodeficiency virus (HIV) positive.
  • Subject is a solid organ transplant recipient.
  • Subject has a urine protein of 3+ or higher by dipstick by the central laboratory at Screening Visit 2.
  • Subject has a history of glomerulonephritis.
Show all 20Show fewer
  • Subject is taking valpromide, progabide, valproic acid, or other known inhibitors of epoxide hydrolase, or subject is taking ranolazine, cyclosporine, azathioprine or mercaptopurine.
  • Subject is receiving chronic treatment with more than 325 mg of salicylates per day.
  • Subject is unable to initiate gout flare prophylaxis with colchicine or low-dose oral corticosteroids at Baseline.
  • Subject is taking any other drug approved for use as a urate-lowering medication other than allopurinol or febuxostat (eg, pegloticase, probenecid, benzbromarone) within 4 weeks prior to Screening or during Screening.
  • For subjects who will be taking colchicine for gout flare prophylaxis: Subject is taking, or anticipated to take during the first 6 months on study, moderate or strong Cytochrome P450 3A4 (CYP3A4) inhibitors (ie, verapamil or diltiazem, clarithromycin, and fluconazole; or grapefruit or grapefruit juice).
  • Subject previously participated in a clinical study involving lesinurad (RDEA594) or verinurad (RDEA3170) and received active treatment or placebo, or has taken commercially-available lesinurad.
  • Subject has a gout flare during the Screening Period.
  • Subject is pregnant or breastfeeding.
  • Subject consumes more than 14 drinks of alcohol per week (eg, 1 drink = 5 oz [150 mL] of wine, 12 oz [360 mL] of beer, or 1.5 oz [45 mL] of hard liquor).
  • Subject has a history of malignancy and has been on active treatment within the previous 5 years prior to randomization with the exception of non-melanoma skin cancer, treated in situ Grade 1 cervical cancer, or treated ductal carcinoma in situ of the breast.
  • Subject has been hospitalized (other than for elective surgery) or received intravenous contrast (eg, for computerized tomography (CT) scan or any angiography) within 1 month prior to Screening or during Screening.
  • Subject has participated in a clinical trial within 8 weeks prior to Screening.
  • Subject has any other medical or psychological condition, which in the opinion of the Investigator might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements or to complete the study.
  • The maximum number of subjects in the eCrCl stratification subgroup has been reached.

Trial locations and contacts

116 sites in 4 countries.

116 sites in 4 countries

United States70 sites

  • New Mexico Clinical Research & Osteoporosis Center Inc.

    Albuquerque, New Mexico, 87106

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • The Kaufmann Clinic, Inc

    Atlanta, Georgia, 30308

  • Ellipsis Group

    Atlanta, Georgia, 30342

  • Ochsner Clinic Foundation

    Baton Rouge, Louisiana, 70809

  • Northeast Clinical Research Center

    Bethlehem, Pennsylvania, 18017

  • Central Alabama Research

    Birmingham, Alabama, 35209

  • Ellipsis Research Group, LLC

    Brooklyn, New York, 11215

  • Buffalo VA Medical Center

    Buffalo, New York, 14215

  • Low Country Rheumatology

    Charleston, South Carolina, 29406

  • DJL Clinical Research PLLC

    Charlotte, North Carolina, 28210

  • Sterling Research Group, Ltd. - Auburn

    Cincinnati, Ohio, 45219

  • Sterling Research Group, Ltd. - Cincinnati

    Cincinnati, Ohio, 45246

  • Medvin Clinical Research

    Covina, California, 91722

  • Clinical Trials Management, LLC - Northshore

    Covington, Louisiana, 70433

  • Spectrum Medical, Inc.

    Danville, Virginia, 24541

  • Arthritis, Autoimmune, & Allergy LLC

    Daytona Beach, Florida, 32117

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635

  • Rhode Island Hospital

    East Providence, Rhode Island, 02914

  • Riverside Clinical Research

    Edgewater, Florida, 32132

  • Center for Arthritis & Osteoporosis

    Elizabethtown, Kentucky, 42701

  • Piedmont Research Partners, LLC

    Fort Mill, South Carolina, 29707

  • Prestige Clinical Research

    Franklin, Ohio, 45005

  • Florida Medical Research Institute

    Gainesville, Florida, 32607

  • PhysiqueMed Clinical Trials

    Greensboro, North Carolina, 27405

  • Mountain View Clinical Research - Greer

    Greer, South Carolina, 29651

  • Clinical Investigation Specialists, Inc. - Gurnee

    Gurnee, Illinois, 60031

  • Eastern Research

    Hialeah, Florida, 33013

  • Rocky Mountain Diabetes and Osteoporosis Center PA

    Idaho Falls, Idaho, 83404

  • CRC of Jackson, LLC

    Jackson, Mississippi, 39202

  • VA Medical Center - Kansas City

    Kansas City, Missouri, 64128

  • Knoxville Kidney Center, PLLC

    Knoxville, Tennessee, 37923

  • FMC Science

    Lampasas, Texas, 76550

  • P&I Clinical Research

    Lufkin, Texas, 75904

  • Manassas Clinical Research Center

    Manassas, Virginia, 20110

  • Nephrology Specialists

    Merrillville, Indiana, 46410

  • Clinical Trials Management LLC - Southshore

    Metairie, Louisiana, 70006

  • San Marcus Research Clinic Inc

    Miami, Florida, 33015

  • LCC Medical Research Institute, LLC

    Miami, Florida, 33126

  • Savin Medical Group

    Miami Lakes, Florida, 33014

  • Winthrop University Hospital

    Mineola, New York, 11501

  • Arthritis and Diabetes Clinic

    Monroe, Louisiana, 71203

  • Burke Primary Care

    Morganton, North Carolina, 28655

  • Discovery Alliance International Inc. d/b/a Tennessee Health Research Alliance LLC

    Nashville, Tennessee, 37203

  • Nephrology Associates, P.C.

    Nashville, Tennessee, 37205

  • Meridian Clinical Research - Norfolk, NE

    Norfolk, Nebraska, 68701

  • Rheumatology Associates of Central Florida

    Orlando, Florida, 32806

  • Omega Research Consultants, LLC

    Orlando, Florida, 32810

  • Four Rivers Clinical Research

    Paducah, Kentucky, 42003

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Michigan Kidney Consultants

    Pontiac, Michigan, 48341

  • Columbia Research Group, Inc.

    Portland, Oregon, 97239

  • Clinical Research Partners, LLC

    Richmond, Virginia, 23235

  • St. Clair Nephrology Research

    Roseville, Michigan, 48066

  • Northern California Research

    Sacramento, California, 95821

  • Capital Nephrology Medical Group

    Sacramento, California, 95825

  • Clinical Advancement Center, PLLC

    San Antonio, Texas, 78215

  • Briggs Clinical Research, Inc.

    San Antonio, Texas, 78224

  • Northwest Louisiana Nephrology

    Shreveport, Louisiana, 71101

  • BayCare Medical Group, Inc.

    Tampa, Florida, 33614

  • Meridien Research - Tampa

    Tampa, Florida, 33634

  • New England Research Associates, Llc

    Trumbull, Connecticut, 06611

  • Southern Arizona VA Health Care System

    Tucson, Arizona, 85723

  • Inland Rheumatology Clinical Trials, Inc

    Upland, California, 91786

  • 3rd Coast Research Associates

    Victoria, Texas, 77901

  • Western Nephrology-Westminster

    Westminster, Colorado, 80031

  • Medvin Clinical Research - Whittier

    Whittier, California, 90602

  • Kansas Nephrology Research Institute

    Wichita, Kansas, 67214

  • Trial Management Associates, LLC

    Wilmington, North Carolina, 28403

  • University of Massachusetts Memorial Medical Center

    Worcester, Massachusetts, 01605

Other trials in United States

Poland22 sites

  • B_Serwis Popenda Sp. J.

    Chorzów, 41-500

  • Centrum Kliniczno Badawcze J. Brzezicki B. Gornikiewicz - Brzezicka Lekarze Sp. p.

    Elblag, 82-300

  • MCBK s.c.

    Grodzisk Mazowiecki, 05-825

  • NZOZ Praktyka Lekarza Rodzinnego Elzbieta Kelm

    Katowice, 40-040

  • Centrum Medyczne Pratia Krakow

    Krakow, 30-002

  • Malopolskie Centrum Medyczne

    Krakow, 30-510

  • Samodzielny Publiczny ZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi, Oddzial Kliniczny Nefrologii, Hipertensjologii i Transplantologii Nerek

    Lodz, 90-153

  • Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo Akcyjna

    Lodz, 90-242

  • AppleTreeClinics Sp. z o.o.

    Lodz, 90-349

  • Centrum Medyczne AMED Oddzial w Lodzi

    Lodz, 91-363

  • NZOZ All - Med Centrum Medyczne Specjalistyczne Gabinety Lekarskie Marcin Ogorek

    Lodz, 94-048

  • Centrum Medyczne Chodzki

    Lublin, 20-093

  • Alfa Specjalistyczne Gabinety Lekarskie Ewa Moroz

    Nowy Sącz, 33-300

  • Centrum Zdrowia Metabolicznego Pawel Bogdanski

    Poznan, 60-589

  • Centrum Badan Klinicznych s.c.

    Poznan, 60-773

  • Praktyka Lekarska Ewa Krzyzagorska

    Poznan, 61-655

  • Prywatny Gabinet Lekarski NZOZ Centrum Medyczne Aeskulap

    Radom, 26-610

  • Centrum Medyczne Pratia Warszawa

    Warsaw, 01-868

  • Centrum Medyczne K2J2

    Wołomin, 05-200

  • KO - MED Centra Kliniczne Sp. z o.o., Osrodek Badan Klinicznych w Zamosciu

    Zamość, 22-400

  • Stacja Dializ Zyrardow

    Żyrardów, Zyrardo, 96-300

  • Centrum Dializa Sp. z o.o. - Zyrardow

    Żyrardów, 96-300

Other trials in Poland

Hungary13 sites

  • Bajai Szent Rokus Korhaz

    Baja, 6500

  • DRC Gyogyszervizsgalo Kozpont Kft

    Balatonfüred, 8230

  • Dr Lakatos Ferenc Belgyogyaszati-Kardiologiai Maganrendelo

    Békéscsaba, 5600

  • Clinexpert Kft.

    Budapest, 1033

  • Vaszary Kolos Korhaz Esztergom - Reumatologiai osztaly

    Esztergom, 2500

  • BKS Research Kft.

    Hatvan, 3000

  • Kalocsai Szent Kereszt Korhaz

    Kalocsa, 6300

  • Selye Janos Hospital - Rheumatology Department

    Komárom, 2921

  • CRU Hungary Kft.

    Miskolc, 3529

  • Mentahaz Maganorvosi Kozpont (SMO)

    Székesfehérvár, 8000

  • Clinfan Ltd SMO

    Szekszárd, 7100

  • Allergo-Derm Bakos Kft.

    Szolnok, 5000

  • Medical Expert Kft.

    Veszprém, 8200

Other trials in Hungary

Czechia11 sites

  • CCBR Czech Brno, s. r. o

    Brno, 60200

  • REVMACLINIC s.r.o. - Revmatologicka ambulance

    Brno, 611 41

  • DTTO Faculty Hospital Brno

    Brno, 62500

  • Revmatologie MUDr. Bilkova s.r.o.

    Olomouc, 779 00

  • CCBR Ostrava s.r.o.

    Ostrava, 70200

  • CCBR Clinical Research, Pardubice

    Pardubice, 53002

  • CCBR Czech Prague s.r.o.

    Prague, 130 00

  • MEDICAL PLUS, s.r.o. - Revmatologicka ambulance

    Uherské Hradiště, 686 01

  • Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z.

    Ústí nad Labem, 40113

  • PV - MEDICAL, s.r.o.

    Zlín, 760 01

  • Nemocnice Znojmo p.o - Interni oddeleni

    Znojmo, 66902

Other trials in Czechia

About this study

Official title: A Phase 4, Study to Evaluate the Safety and Efficacy of Lesinurad 200 mg in Combination With a Xanthine Oxidase Inhibitor (XOI), Compared With an XOI Alone, in Subjects With Gout and Estimated Creatinine Clearance (eCrCl) 30 to <60 mL/Min Who Have Not Achieved Target Serum Uric Acid Levels (sUA) on an XOI Alone

This study evaluates the safety and efficacy of lesinurad administered with an XOI versus a placebo plus an XOI in gout participants who have moderate renal impairment and who are not at target level of serum urate (sUA).

Read the detailed description

This postmarketing study is a randomized, double-blind, placebo-controlled study to evaluate safety (with particular focus on renal and cardiovascular events) and efficacy of lesinurad 200 mg once daily (QD) in combination with an XOI for up to 24 months compared with XOI monotherapy, in participants with gout and moderate renal impairment who have not reached target sUA levels (<6.0 mg/dL) on an XOI alone.

Being tested
Lesinurad, XOI, Placebo, colchicine, corticosteroids
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.

  • LesinuradDrug

    Also called RDEA594

    200 mg oral tablet

  • XOIDrug

    Also called allopurinol, febuxostat

    All participants must be on a stable, medically appropriate dose of XOI as their sole urate-lowering therapy (ULT) indicated for the treatment of gout for at least 4 weeks prior to Screening and throughout the Screening Period. This stable dose of XOI will be maintained throughout the study period.

  • PlaceboDrug

    matching placebo oral tablet

  • colchicineDrug

    Gout flare prophylaxis: commercially available colchicine is provided through the Month 6 study visit. Actual colchicine dose (0.5 or 0.6 mg qd) and frequency were adjusted based on the local label, subject medical history, and clinical judgement.

  • corticosteroidsDrug

    Gout flare prophylaxis: Participants unable to take colchicine are permitted to take a short course of low-dose oral corticosteroids up to the Month 3 study visit

Study groups in NCT03226899
Study groupRoleWhat they receive
Lesinurad + XOIActive comparatorlesinurad 200 mg oral tablet QD plus a stable, medically appropriate dose of an XOI
Receives: Drug: Lesinurad; Drug: XOI; Drug: colchicine; Drug: corticosteroids
Placebo + XOIPlacebo comparatorplacebo tablet QD plus a stable, medically appropriate dose of an XOI
Receives: Drug: XOI; Drug: Placebo; Drug: colchicine; Drug: corticosteroids

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Who Achieve Serum Urate (sUA) < 6.0 mg/dL at Month 6

    Measured: Month 6

Secondary outcomes (13)

  1. Percentage of Participants Who Achieve sUA < 6.0 mg/dL Over Time

    Measured: Baseline, Months 1, 3, 6, 9, 12, 15, 18

  2. Change From Baseline in sUA Over Time, Including the Last Value On and Off Treatment

    Measured: Baseline, Months 1, 3, 6, 9, 12, 15, 18

  3. Percent Change From Baseline in sUA Over Time, Including the Last Value On and Off Treatment

    Measured: Baseline, Months 1, 3, 6, 9, 12, 15, 18

  4. Change From Baseline in Estimated Creatinine Clearance (eCrCl) at Month 24

    The eCrCl was calculated by the Cockcroft-Gault formula using ideal body weight.

    Measured: Baseline, 24 months

  5. Percent Change From Baseline in eCrCl at Month 24

    The eCrCl was calculated by the Cockcroft-Gault formula using ideal body weight.

    Measured: Baseline, 24 months

  6. Change From Baseline in eCrCl Over the Study Period, Including the Last Value On and Off Treatment

    The eCrCl was calculated by the Cockcroft-Gault formula using ideal body weight.

    Measured: Baseline, Months 1, 3, 6, 9, 12, 15, 18

  7. Percent Change From Baseline in eCrCl Over the Study Period, Including the Last Value On and Off Treatment

    The eCrCl was calculated by the Cockcroft-Gault formula using ideal body weight.

    Measured: Baseline, Months 1, 3, 6, 9, 12, 15, 18

  8. Percentage of Participants With Serum Creatinine (sCr) Elevations (≥1.5 × Baseline) Over the Study Period

    Measured: up to 18 months

  9. Percentage of Participants Meeting Criteria (eg, Based on sCr or eCrCl Criteria) for Treatment Discontinuations Over the Study Period

    Kidney function was monitored throughout the study by measuring sCr and calculating eCrCl by Cockcroft-Gault formula using ideal body weight. Treatment discontinuations were required if a participant experienced an absolute sCr ≥4.0 mg/dL or an eCrCl <20 mL/min (based on central laboratory results).

    Measured: up to 18 months

  10. Percentage of Participants Renal-Related and Kidney Stone Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Renal-related and kidney stone events were based on Medical Dictionary for Regulatory Activities (MedDRA) "Renal and Urinary Disorders" system organ classification. AEs that started on or after the first dose of study drug in this study, or those AEs with onset prior to the first dose of study drug but worsened after the first dose of study drug, were considered treatment emergent.

    Measured: From first dose of study drug through each participant's study duration, up to approximately 18 months.

  11. Percentage of Participants With Contributing Factors to Renal SAEs as Adjudicated by the Renal Event Adjudication Committee (REAC)

    Measured: From first dose of study drug through each participant's study duration, up to approximately 18 months.

  12. Percentage of Participants With Cardiac Event Adjudication Committee (CEAC)-Adjudicated Major Adverse Cardiovascular Events (MACEs)

    MACEs are defined as Cardiovascular Death, Nonfatal Myocardial Infarction, and Nonfatal Stroke.

    Measured: From first dose of study drug through each participant's study duration, up to approximately 18 months.

  13. Incidence of CEAC-Adjudicated MACEs or Hospitalization for Unstable Angina (MACE+)

    MACEs are defined as Cardiovascular Death, Nonfatal Myocardial Infarction, and Nonfatal Stroke.

    Measured: From first dose of study drug through each participant's study duration, up to approximately 18 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2017
  2. Study start19 Jul 2017
  3. Primary completion25 Feb 2019
  4. Study completion25 Feb 2019

Why it stopped: This action was a business decision \& not related to any efficacy, safety or clinical concerns with lesinurad.

Resources

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
Model description
Randomized, Double-Blind, Multicenter, Placebo-Controlled
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
242 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03226899
Sponsor's protocol ID
RDEA594-401
Status last verified
Oct 2021
First submitted
20 Jul 2017
Last updated
4 Nov 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lesinurad, XOI and colchicine in people with Gout and Chronic Kidney Disease (CKD), run by Ironwood Pharmaceuticals, Inc. at 116 sites in 4 countries.

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 9 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: stopped early, as of the sponsor's last update on 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 116 sites in United States, Poland, Hungary, Czechia. 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?

Yes. Results are posted in the registry (first posted 4 Nov 2021). 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 Who Achieve Serum Urate (sUA) < 6.0 mg/dL at Month 6 (time frame: Month 6). 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 NCT03226899.

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 4 Nov 2021.

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