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Clinical Trial Details

Trial ID: L0145
Source ID: NCT03990363
Associated Drug: Verinurad
Title: A Study of Verinurad and Allopurinol in Patients With Chronic Kidney Disease and Hyperuricaemia
Acronym: SAPPHIRE
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03990363/results
Conditions: Chronic Kidney Disease
Interventions: DRUG: Verinurad|DRUG: Allopurinol|DRUG: Placebo for Verinurad|DRUG: Placebo for Allopurinol
Outcome Measures: Primary: Urinary Albumin to Creatinine Ratio (uACR) (mg/g) Change From Baseline at 6 Months (Visit 8), Repeated Measures Mixed Model (MMRM), Analyses of change from baseline in uACR at 6 months (Visit 8) focused on: * High dose vs Placebo * High dose and Inter. dose combined vs Allopurinol alone * Inter. dose vs Placebo * Low dose vs Placebo * High dose vs Allopurinol * Inter. dose vs Allopurinol * Low dose vs Allopurinol * Allopurinol vs Placebo For High dose and Inter. dose combined the 2 categories merged forming 1 new temporary category., Baseline to 9 months (Visit 9); analysis at 6 months (Visit 8) | Secondary: Urinary Albumin to Creatinine Ratio (uACR) (mg/g) Change From Baseline at 12 Months (Visit 10), Repeated Measures Mixed Model (MMRM), Change from baseline in uACR at 12 months (Visit 10) for comparison of Switch dose protocol version 5.0 (PA5) versus double-capsule Placebo. The statistical model applied was an MMRM, which was basically the same as the one applied in the primary analysis but adjusted for a 12 month horizon and adapted to the double-capsule regimen from Visit 9 on., Baseline to 12 months (Visit 10); analysis at 12 months (Visit 10)|Serum Uric Acid (sUA) (mg/dL) Change From Baseline at 6 Months (Visit 8), Repeated Measures Mixed Model (MMRM), Change from baseline in sUA at 6 months (Visit 8), there were 7 comparisons requested for each endpoint, namely: * High dose vs Placebo * Inter. dose vs Placebo * Low dose vs Placebo * High dose vs Allopurinol * Inter. dose vs Allopurinol * Low dose vs Allopurinol * Allopurinol vs Placebo., Baseline to 9 months (Visit 9); analysis at 6 months (Visit 8)|Serum Uric Acid (sUA) Change From Baseline at 12 Months (Visit 10), Repeated Measures Mixed Model (MMRM), Change from baseline in sUA at 12 months (Visit 10) for comparison of Switch dose protocol version 5.0 (PA5) versus double-capsule Placebo., Baseline to 12 months (Visit 10); analysis at 12 months (Visit 10)|Estimated Glomerular Filtration Rate (eGFR) (mL/Min/1.73 m²) Change From Baseline at 6 Months (V8), Repeated Measures Mixed Model (MMRM), Change from baseline in eGFR at 6 months (Visit 8), there were 7 comparisons requested for this endpoint, namely: * High dose vs Placebo * Inter. dose vs Placebo * Low dose vs Placebo * High dose vs Allopurinol * Inter. dose vs Allopurinol * Low dose vs Allopurinol * Allopurinol vs Placebo., Baseline to 9 months (Visit 9); analysis at 6 months (Visit 8)|Estimated Glomerular Filtration Rate (eGFR) (mL/Min/1.73 m²) Change From Baseline at 12 Months (Visit 10), Change from baseline in eGFR at 12 months (Visit 10) for the following treatments: * High Dose * Inter. Dose * Low Dose (a) * Switch Dose protocol version 5.0 (PA5) (b) * Allopurinol * Placebo 1. Subjects that switched from Verinurad 3 mg to Verinurad 24 mg at Visit 9 are not included in this group for Visit 10. 2. Contains all subjects randomized to the low dose group that later switched to Verinurad 24 mg plus Allopurinol 300 mg., Change from baseline to 12 months (Visit 10)|S-creatinine (mg/dL) Change From Baseline at 6 Months (V8), Repeated Measures Mixed Model (MMRM), Change from baseline in S-creatinine at 6 months (Visit 8), there were 7 comparisons requested for this endpoint, namely: * High dose vs Placebo * Inter. dose vs Placebo * Low dose vs Placebo * High dose vs Allopurinol * Inter. dose vs Allopurinol * Low dose vs Allopurinol * Allopurinol vs Placebo., Baseline to 9 months (Visit 9); analysis at 6 months (Visit 8)|S-creatinine (mg/dL) Change From Baseline at 12 Months (Visit 10), Change from baseline in S-creatinine at 12 months (Visit 10) for the following treatments: * High Dose * Inter. Dose * Low Dose (a) * Switch Dose protocol version 5.0 (PA5) (b) * Allopurinol * Placebo 1. Subjects that switched from Verinurad 3 mg to Verinurad 24 mg at Visit 9 are not included in this group for Visit 10. 2. Contains all subjects randomized to the low dose group that later switched to Verinurad 24 mg plus Allopurinol 300 mg., Change from baseline to 12 months (Visit 10)|P-cystatin C (mg/L) Change From Baseline at 6 Months (V8), Repeated Measures Mixed Model (MMRM), Change from baseline in P-cystatin C at 6 months (Visit 8), there were 7 comparisons requested for this endpoint, namely: * High dose vs Placebo * Inter. dose vs Placebo * Low dose vs Placebo * High dose vs Allopurinol * Inter. dose vs Allopurinol * Low dose vs Allopurinol * Allopurinol vs Placebo., Baseline to 9 months (Visit 9); analysis at 6 months (Visit 8)|P-cystatin C (mg/L) Change From Baseline at 12 Months (Visit 10), Change from baseline in S-creatinine at 12 months (Visit 10) for the following treatments: * High Dose * Inter. Dose * Low Dose (a) * Switch Dose protocol version 5.0 (PA5) (b) * Allopurinol * Placebo 1. Subjects that switched from Verinurad 3 mg to Verinurad 24 mg at Visit 9 are not included in this group for Visit 10. 2. Contains all subjects randomized to the low dose group that later switched to Verinurad 24 mg plus Allopurinol 300 mg., Change from baseline to 12 months (Visit 10)
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 861
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2019-07-23
Completion Date: 2021-11-22
Results First Posted: 2023-03-02
Last Update Posted: 2023-03-02
Locations: Research Site, Huntsville, Alabama, 35805, United States|Research Site, Bakersfield, California, 93309, United States|Research Site, Canyon Country, California, 91351, United States|Research Site, Laguna Hills, California, 92653, United States|Research Site, Long Beach, California, 90807, United States|Research Site, Northridge, California, 91324, United States|Research Site, Orange, California, 92868, United States|Research Site, Thousand Oaks, California, 91360, United States|Research Site, Vacaville, California, 95687, United States|Research Site, Victorville, California, 92395, United States|Research Site, Denver, Colorado, 80230, United States|Research Site, Bloomfield, Connecticut, 06002, United States|Research Site, Washington, District of Columbia, 20037, United States|Research Site, Altamonte Springs, Florida, 32701, United States|Research Site, Hialeah, Florida, 33012, United States|Research Site, Jacksonville, Florida, 32204, United States|Research Site, Lauderdale Lakes, Florida, 33313, United States|Research Site, Miami Lakes, Florida, 33014, United States|Research Site, Miami, Florida, 33015, United States|Research Site, Miami, Florida, 33126-2956, United States|Research Site, Miami, Florida, 33165, United States|Research Site, Ocala, Florida, 34471, United States|Research Site, Ocoee, Florida, 34761, United States|Research Site, Pembroke Pines, Florida, 33026, United States|Research Site, Port Charlotte, Florida, 33952, United States|Research Site, Lawrenceville, Georgia, 30046, United States|Research Site, Wauconda, Illinois, 60084, United States|Research Site, Paducah, Kentucky, 42003, United States|Research Site, Takoma Park, Maryland, 20912, United States|Research Site, Flint, Michigan, 48504, United States|Research Site, Flint, Michigan, 48532, United States|Research Site, Saint Clair Shores, Michigan, 48081, United States|Research Site, Minneapolis, Minnesota, 55404, United States|Research Site, Bronx, New York, 10461, United States|Research Site, Jamaica, New York, 11432, United States|Research Site, Asheville, North Carolina, 28801, United States|Research Site, Asheville, North Carolina, 28803, United States|Research Site, Rocky Mount, North Carolina, 27804, United States|Research Site, Wilmington, North Carolina, 28401, United States|Research Site, Winston-Salem, North Carolina, 27103, United States|Research Site, Philadelphia, Pennsylvania, 19107, United States|Research Site, Orangeburg, South Carolina, 29118, United States|Research Site, Knoxville, Tennessee, 37923, United States|Research Site, Arlington, Texas, 76015, United States|Research Site, El Paso, Texas, 79935, United States|Research Site, Houston, Texas, 77004, United States|Research Site, Lampasas, Texas, 76550, United States|Research Site, Lewisville, Texas, 75057, United States|Research Site, Pearland, Texas, 77584, United States|Research Site, San Antonio, Texas, 78212, United States|Research Site, San Antonio, Texas, 78231, United States|Research Site, San Antonio, Texas, 78258, United States|Research Site, Alexandria, Virginia, 22304, United States|Research Site, Milwaukee, Wisconsin, 53226, United States|Research Site, Frydek, 738 01, Czechia|Research Site, Praha 2, 128 08, Czechia|Research Site, Praha 6, 160 00, Czechia|Research Site, Slany, 274 01, Czechia|Research Site, Třebíč, 674 01, Czechia|Research Site, Annonay, 07103, France|Research Site, Grenoble cedex 9, 38043, France|Research Site, Marseille cedex 5, 13385, France|Research Site, Paris, 75018, France|Research Site, Paris, 75970, France|Research Site, Rouen, 76031, France|Research Site, Tours, 37000, France|Research Site, Baja, 6500, Hungary|Research Site, Balatonfured, 8230, Hungary|Research Site, Budapest, 1033, Hungary|Research Site, Budapest, 1036, Hungary|Research Site, Debrecen, 4025, Hungary|Research Site, Debrecen, 4032, Hungary|Research Site, Hatvan, 3000, Hungary|Research Site, Kaposvár, 7400, Hungary|Research Site, Nyíregyháza, 4400, Hungary|Research Site, Nyíregyháza, 4405, Hungary|Research Site, Szeged, 6725, Hungary|Research Site, Zalaegerszeg, 8900, Hungary|Research Site, Afula, 1834111, Israel|Research Site, Ashdod, 77000, Israel|Research Site, Ashkelon, 78278, Israel|Research Site, Beer Sheba, 8410101, Israel|Research Site, Haifa, 3109601, Israel|Research Site, Haifa, 34362, Israel|Research Site, Haifa, 35152, Israel|Research Site, Holon, 58100, Israel|Research Site, Kfar Sava, 44281, Israel|Research Site, Nahariya, 22100, Israel|Research Site, Nazareth, 16100, Israel|Research Site, Petach-Tikva, 49100, Israel|Research Site, Ramat Gan, 52621, Israel|Research Site, Rehovot, 7642001, Israel|Research Site, Safed, 13100, Israel|Research Site, Tel-Aviv, 61480, Israel|Research Site, Tiberias, 15208, Israel|Research Site, Genova, 16132, Italy|Research Site, Milano, 20132, Italy|Research Site, Parma, 43126, Italy|Research Site, Pavia, 27100, Italy|Research Site, Verona, 37124, Italy|Research Site, Ciudad Madero, 89440, Mexico|Research Site, Estado de Mexico, 54800, Mexico|Research Site, Guadalajara, 44650, Mexico|Research Site, Mexico, 03100, Mexico|Research Site, Mexico, 06700, Mexico|Research Site, Tijuana, 22500, Mexico|Research Site, Veracruz, 91910, Mexico|Research Site, Krakow, 31-559, Poland|Research Site, Lodz, 90-302, Poland|Research Site, Lublin, 20-538, Poland|Research Site, Poznań, 61-655, Poland|Research Site, Rzeszów, 35-055, Poland|Research Site, Warszawa, 00-465, Poland|Research Site, Wroclaw, 50-127, Poland|Research Site, Bucuresti, 010192, Romania|Research Site, Bucuresti, 010825, Romania|Research Site, Bucuresti, 050538, Romania|Research Site, Bucuresti, 40172, Romania|Research Site, Deva, 330084, Romania|Research Site, Ploiesti, 100342, Romania|Research Site, Satu Mare, 440055, Romania|Research Site, Timișoara, 300456, Romania|Research Site, Bardejov, 085 01, Slovakia|Research Site, Bratislava, 85101, Slovakia|Research Site, Hlohovec, 920 01, Slovakia|Research Site, Kosice, Slovakia|Research Site, Kralovsky Chlmec, 077 01, Slovakia|Research Site, Lucenec, 984 01, Slovakia|Research Site, Puchov, 2001, Slovakia|Research Site, Rimavska Sobota, 979 01, Slovakia|Research Site, Svidnik, 08901, Slovakia|Research Site, Benoni, 1501, South Africa|Research Site, Cape Town, 1730, South Africa|Research Site, Cape Town, 7505, South Africa|Research Site, Cape Town, 7570, South Africa|Research Site, Cape Town, 7925, South Africa|Research Site, Durban, 4001, South Africa|Research Site, Durban, 4092, South Africa|Research Site, George, 6530, South Africa|Research Site, Johannesburg, 2001, South Africa|Research Site, Johannesburg, 2132, South Africa|Research Site, Krugersdorp, 1739, South Africa|Research Site, Lenasia, 1827, South Africa|Research Site, Paarl, 7647, South Africa|Research Site, Stanger, 4450, South Africa|Research Site, Tshwane, 0084, South Africa|Research Site, Worcester, 6850, South Africa|Research Site, Alicante, 03010, Spain|Research Site, Alicante, 03550, Spain|Research Site, Barcelona, 08003, Spain|Research Site, Barcelona, 08023, Spain|Research Site, Barcelona, 08035, Spain|Research Site, Barcelona, 08036, Spain|Research Site, Ciudad Real, 13005, Spain|Research Site, Cordoba, 14004, Spain|Research Site, Girona, 17007, Spain|Research Site, Granada, 18012, Spain|Research Site, L'Hospitalet De Llobregat, 08907, Spain|Research Site, Málaga, 29011, Spain|Research Site, Palma de Mallorca, 7120, Spain|Research Site, Puerto De Sagunto, 46520, Spain|Research Site, Santander, 39010, Spain|Research Site, Sevilla, 41071, Spain|Research Site, Valencia, 46014, Spain|Research Site, Valencia, 46017, Spain
URL: https://clinicaltrials.gov/show/NCT03990363

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D511 Verinurad small molecule DB11873 Details