A Study of Verinurad and Allopurinol in Patients With Chronic Kidney Disease and Hyperuricaemia (SAPPHIRE)

A Phase 2b, Multicentre, Randomised, Double-blind, Placebo-controlled Study of Verinurad and Allopurinol in Patients With Chronic KIdney Disease and Hyperuricaemia

The purpose of this clinical research study is to establish the dose of verinurad combined with allopurinol 300 mg once daily that will elicit the desired response; ie, reduction in urinary albumin to creatinine ratio (UACR) at 6 months.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Drug: Verinurad; Drug: Allopurinol; Drug: Placebo for Verinurad; Drug: Placebo for Allopurinol

Detailed Description

Evidence shows independent associations between hyperuricaemia and the risk of hypertension, myocardial infarction, chronic kidney disease (CKD), type 2 diabetes, heart failure, and metabolic syndrome, including obesity Furthermore, gout, an inflammatory arthritis caused by deposition of monosodium urate crystals in joints, is associated with an increased risk of all-cause death, as well as cardiovascular (CV) death.

Hyperuricaemia is a prerequisite for development of gout, thus linking high levels of sUA to gout and to poor outcomes. However, the causal relationship between hyperuricaemia / gout and the aforementioned diseases and outcomes remains to be proven.

Uric acid transporter 1 (URAT1) is responsible for reabsorption of uric acid (UA in the proximal tubule. Inhibition of URAT1 results in increased urinary excretion of UA.

Verinurad (RDEA3170) is a novel URAT1 inhibitor in Phase 2 development for chronic kidney disease and heart failure.

Verinurad combined with the xanthine oxidase (XO)inhibitor (XOI) febuxostat or allopurinol has been shown to lower sUA in patients with recurrent gout in Phase 2 studies by up to 80%..

The primary objective of this study is to assess the effects of treatment with verinurad and allopurinol, allopurinol alone, and placebo on UACR at 6 months.

In this study, change in UACR at 6 months of treatment is the primary endpoint for the efficacy evaluation of treatment with the combination of verinurad and allopurinol vs. placebo.

A key secondary objective is evaluation of verinurad plus allopurinol on the reduction in UACR at 12 months.

Further, standard safety parameters such as adverse event (AEs), serious adverse event (SAEs), and laboratory evaluations will be employed to assess the safety profile of the study drugs.

Verinurad, allopurinol and oxypurinol plasma concentrations over time will also be measured.

The study will recruit patients with Chronic Kidney Disease and Hyperuricaemia.

• Study Type: Interventional
• Enrollment (Actual): 861
• Phase: Phase 2

Contacts and Locations

Study Locations

• Czechia
  • Frydek, Czechia, 738 01
    • Research Site
  • Praha 2, Czechia, 128 08
    • Research Site
  • Praha 6, Czechia, 160 00
    • Research Site
  • Slany, Czechia, 274 01
    • Research Site
  • Třebíč, Czechia, 674 01
    • Research Site
• France
  • Annonay, France, 07103
    • Research Site
  • Grenoble cedex 9, France, 38043
    • Research Site
  • Marseille cedex 5, France, 13385
    • Research Site
  • Paris, France, 75018
    • Research Site
  • Paris, France, 75970
    • Research Site
  • Rouen, France, 76031
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  • Tours, France, 37000
    • Research Site
• Hungary
  • Baja, Hungary, 6500
    • Research Site
  • Balatonfured, Hungary, 8230
    • Research Site
  • Budapest, Hungary, 1033
    • Research Site
  • Budapest, Hungary, 1036
    • Research Site
  • Debrecen, Hungary, 4032
    • Research Site
  • Debrecen, Hungary, 4025
    • Research Site
  • Hatvan, Hungary, 3000
    • Research Site
  • Kaposvár, Hungary, 7400
    • Research Site
  • Nyíregyháza, Hungary, 4400
    • Research Site
  • Nyíregyháza, Hungary, 4405
    • Research Site
  • Szeged, Hungary, 6725
    • Research Site
  • Zalaegerszeg, Hungary, 8900
    • Research Site
• Israel
  • Afula, Israel, 1834111
    • Research Site
  • Ashdod, Israel, 77000
    • Research Site
  • Ashkelon, Israel, 78278
    • Research Site
  • Beer Sheba, Israel, 8410101
    • Research Site
  • Haifa, Israel, 34362
    • Research Site
  • Haifa, Israel, 3109601
    • Research Site
  • Haifa, Israel, 35152
    • Research Site
  • Holon, Israel, 58100
    • Research Site
  • Kfar Sava, Israel, 44281
    • Research Site
  • Nahariya, Israel, 22100
    • Research Site
  • Nazareth, Israel, 16100
    • Research Site
  • Petach-Tikva, Israel, 49100
    • Research Site
  • Ramat Gan, Israel, 52621
    • Research Site
  • Rehovot, Israel, 7642001
    • Research Site
  • Safed, Israel, 13100
    • Research Site
  • Tel-Aviv, Israel, 61480
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  • Tiberias, Israel, 15208
    • Research Site
• Italy
  • Genova, Italy, 16132
    • Research Site
  • Milano, Italy, 20132
    • Research Site
  • Parma, Italy, 43126
    • Research Site
  • Pavia, Italy, 27100
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  • Verona, Italy, 37124
    • Research Site
• Mexico
  • Ciudad Madero, Mexico, 89440
    • Research Site
  • Estado de Mexico, Mexico, 54800
    • Research Site
  • Guadalajara, Mexico, 44650
    • Research Site
  • Mexico, Mexico, 06700
    • Research Site
  • Mexico, Mexico, 03100
    • Research Site
  • Tijuana, Mexico, 22500
    • Research Site
  • Veracruz, Mexico, 91910
    • Research Site
• Poland
  • Krakow, Poland, 31-559
    • Research Site
  • Lodz, Poland, 90-302
    • Research Site
  • Lublin, Poland, 20-538
    • Research Site
  • Poznań, Poland, 61-655
    • Research Site
  • Rzeszów, Poland, 35-055
    • Research Site
  • Warszawa, Poland, 00-465
    • Research Site
  • Wroclaw, Poland, 50-127
    • Research Site
• Romania
  • Bucuresti, Romania, 010192
    • Research Site
  • Bucuresti, Romania, 010825
    • Research Site
  • Bucuresti, Romania, 050538
    • Research Site
  • Bucuresti, Romania, 40172
    • Research Site
  • Deva, Romania, 330084
    • Research Site
  • Ploiesti, Romania, 100342
    • Research Site
  • Satu Mare, Romania, 440055
    • Research Site
  • Timișoara, Romania, 300456
    • Research Site
• Slovakia
  • Bardejov, Slovakia, 085 01
    • Research Site
  • Bratislava, Slovakia, 85101
    • Research Site
  • Hlohovec, Slovakia, 920 01
    • Research Site
  • Kosice, Slovakia
    • Research Site
  • Kralovsky Chlmec, Slovakia, 077 01
    • Research Site
  • Lucenec, Slovakia, 984 01
    • Research Site
  • Puchov, Slovakia, 2001
    • Research Site
  • Rimavska Sobota, Slovakia, 979 01
    • Research Site
  • Svidnik, Slovakia, 08901
    • Research Site
• South Africa
  • Benoni, South Africa, 1501
    • Research Site
  • Cape Town, South Africa, 7570
    • Research Site
  • Cape Town, South Africa, 1730
    • Research Site
  • Cape Town, South Africa, 7505
    • Research Site
  • Cape Town, South Africa, 7925
    • Research Site
  • Durban, South Africa, 4001
    • Research Site
  • Durban, South Africa, 4092
    • Research Site
  • George, South Africa, 6530
    • Research Site
  • Johannesburg, South Africa, 2001
    • Research Site
  • Johannesburg, South Africa, 2132
    • Research Site
  • Krugersdorp, South Africa, 1739
    • Research Site
  • Lenasia, South Africa, 1827
    • Research Site
  • Paarl, South Africa, 7647
    • Research Site
  • Stanger, South Africa, 4450
    • Research Site
  • Tshwane, South Africa, 0084
    • Research Site
  • Worcester, South Africa, 6850
    • Research Site
• Spain
  • Alicante, Spain, 03010
    • Research Site
  • Alicante, Spain, 03550
    • Research Site
  • Barcelona, Spain, 08035
    • Research Site
  • Barcelona, Spain, 08036
    • Research Site
  • Barcelona, Spain, 08003
    • Research Site
  • Barcelona, Spain, 08023
    • Research Site
  • Ciudad Real, Spain, 13005
    • Research Site
  • Cordoba, Spain, 14004
    • Research Site
  • Girona, Spain, 17007
    • Research Site
  • Granada, Spain, 18012
    • Research Site
  • L'Hospitalet De Llobregat, Spain, 08907
    • Research Site
  • Málaga, Spain, 29011
    • Research Site
  • Palma de Mallorca, Spain, 7120
    • Research Site
  • Puerto De Sagunto, Spain, 46520
    • Research Site
  • Santander, Spain, 39010
    • Research Site
  • Sevilla, Spain, 41071
    • Research Site
  • Valencia, Spain, 46014
    • Research Site
  • Valencia, Spain, 46017
    • Research Site
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35805
      • Research Site
  • California
    • Bakersfield, California, United States, 93309
      • Research Site
    • Canyon Country, California, United States, 91351
      • Research Site
    • Laguna Hills, California, United States, 92653
      • Research Site
    • Long Beach, California, United States, 90807
      • Research Site
    • Northridge, California, United States, 91324
      • Research Site
    • Orange, California, United States, 92868
      • Research Site
    • Thousand Oaks, California, United States, 91360
      • Research Site
    • Vacaville, California, United States, 95687
      • Research Site
    • Victorville, California, United States, 92395
      • Research Site
  • Colorado
    • Denver, Colorado, United States, 80230
      • Research Site
  • Connecticut
    • Bloomfield, Connecticut, United States, 06002
      • Research Site
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • Research Site
  • Florida
    • Altamonte Springs, Florida, United States, 32701
      • Research Site
    • Hialeah, Florida, United States, 33012
      • Research Site
    • Jacksonville, Florida, United States, 32204
      • Research Site
    • Lauderdale Lakes, Florida, United States, 33313
      • Research Site
    • Miami, Florida, United States, 33165
      • Research Site
    • Miami, Florida, United States, 33015
      • Research Site
    • Miami, Florida, United States, 33126-2956
      • Research Site
    • Miami Lakes, Florida, United States, 33014
      • Research Site
    • Ocala, Florida, United States, 34471
      • Research Site
    • Ocoee, Florida, United States, 34761
      • Research Site
    • Pembroke Pines, Florida, United States, 33026
      • Research Site
    • Port Charlotte, Florida, United States, 33952
      • Research Site
  • Georgia
    • Lawrenceville, Georgia, United States, 30046
      • Research Site
  • Illinois
    • Wauconda, Illinois, United States, 60084
      • Research Site
  • Kentucky
    • Paducah, Kentucky, United States, 42003
      • Research Site
  • Maryland
    • Takoma Park, Maryland, United States, 20912
      • Research Site
  • Michigan
    • Flint, Michigan, United States, 48504
      • Research Site
    • Flint, Michigan, United States, 48532
      • Research Site
    • Saint Clair Shores, Michigan, United States, 48081
      • Research Site
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Research Site
  • New York
    • Bronx, New York, United States, 10461
      • Research Site
    • Jamaica, New York, United States, 11432
      • Research Site
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Research Site
    • Asheville, North Carolina, United States, 28803
      • Research Site
    • Rocky Mount, North Carolina, United States, 27804
      • Research Site
    • Wilmington, North Carolina, United States, 28401
      • Research Site
    • Winston-Salem, North Carolina, United States, 27103
      • Research Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Research Site
  • South Carolina
    • Orangeburg, South Carolina, United States, 29118
      • Research Site
  • Tennessee
    • Knoxville, Tennessee, United States, 37923
      • Research Site
  • Texas
    • Arlington, Texas, United States, 76015
      • Research Site
    • El Paso, Texas, United States, 79935
      • Research Site
    • Houston, Texas, United States, 77004
      • Research Site
    • Lampasas, Texas, United States, 76550
      • Research Site
    • Lewisville, Texas, United States, 75057
      • Research Site
    • Pearland, Texas, United States, 77584
      • Research Site
    • San Antonio, Texas, United States, 78212
      • Research Site
    • San Antonio, Texas, United States, 78258
      • Research Site
    • San Antonio, Texas, United States, 78231
      • Research Site
  • Virginia
    • Alexandria, Virginia, United States, 22304
      • Research Site
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 130 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The subject has given written informed consent prior to any mandatory study specific procedures, sampling, and analyses, and is able to understand and comply with all study procedures
• Adult Patient ≥18 years of age with CKD for >3 months.
• Patients with background standard of care treatment for albuminuria and/or T2DM and treated according to locally recognised guidelines. Therapy optimised and stable for ≥4 weeks before study entry and including an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker, unless justified.
• If treated with a sodium-glucose transport protein (SGLT2) inhibitor, stable dose for ≥4 weeks before randomisation.
• Meeting screening criteria for sUA and eGFR (Visit 2): sUA ≥6.0 mg/dL. ∙ eGFR ≥25 mL/min/1.73 m2 Chronic Kidney Disease Epidemiology Collaboration
• UACR between 30 mg/g and 5000 mg/g.
• Female patients: Negative pregnancy test for childbearing potential. 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception during the study and 4 weeks after the last dose of study treatment.

Exclusion Criteria:

• Autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis or anti-neutrophil cytoplasmic antibody associated vasculitis (granulomatosis with polyangiitis [Wegener's granulomatosis], microscopic polyangiitis, or eosinophilic granulomatosis with polyangiitis [Churg-Strauss syndrome]).
• History of renal transplantation
• Known carrier of the Human Leukocyte Antigen-B *58:01 allele.
• Patients diagnosed with tumor lysis syndrome or Lesch-Nyhan syndrome
• Patients who in the opinion of investigator are unable to perform the patients' tasks associated with the protocol or Presence of any condition which, places the patient at undue risk or potentially jeopardises the quality of the data to be generated
• History of stroke, myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft in the past 6 months
• Uncontrolled hypertension presenting with systolic blood pressure >180 mm Hg and/or diastolic blood pressure >100 mm Hg
• Diagnosed with heart failure and New York Heart Association Functional Classification Class IV at the time of randomisation
• QT interval corrected by the Fridericia formula >470 msec; patients diagnosed with long QT syndrome; patients with a family history of long QT syndrome.
• Subjects with severe hepatic impairment, as judged by the investigator, of Child-Pugh Class C (decompensated cirrhosis), or with major cirrhosis complications (eg, hepatorenal syndrome)
• Receiving cytotoxic or immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment
• Treated with any drug for hyperuricaemia in the 6 months preceding randomisation.
• Dose of ACEi, ARBs, fenofibrate, guaifenesin, or SGLT2 inhibitors changed within 4 weeks of randomisation or further dose titration expected after randomization

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Dose; High Dose (mg) (verinurad/allopurinol) Step 1 - titration_ 3/100 Step 2 - titration_ 7.5/200 Step 3 - target dose_ 12/300	Drug: Verinurad; Study treatments will be titrated in 3 steps for target low dose (3 mg), intermediate dose ( 7.5 mg) and High Dose (12 mg) Verinurad. As per Protocol Version 5.0, Patients from 3 mg dose will be switched to 24 mg at visit 9; Drug: Allopurinol; Study treatments will be titrated in 3 steps: Low dose (100 mg), intermediate (200 mg) and High Dose ( 300 mg) Allopurinol
Experimental: Intermediate Dose; Intermediate Dose (mg) verinurad/allopurinol Step 1 - titration_ 3/100 Step 2 - titration_ 7.5/200 Step 3 - target dose_ 7.5/300	Drug: Verinurad; Study treatments will be titrated in 3 steps for target low dose (3 mg), intermediate dose ( 7.5 mg) and High Dose (12 mg) Verinurad. As per Protocol Version 5.0, Patients from 3 mg dose will be switched to 24 mg at visit 9; Drug: Allopurinol; Study treatments will be titrated in 3 steps: Low dose (100 mg), intermediate (200 mg) and High Dose ( 300 mg) Allopurinol
Experimental: Low Dose; Low Dose (mg) verinurad/allopurinol Step 1 - titration_3/100 Step 2 - titration_3/200 Step 3 - target dose_3/300. As per Protocol Version 5.0, Patients from 3 mg dose will be switched to 24 mg at Visit 9.	Drug: Verinurad; Study treatments will be titrated in 3 steps for target low dose (3 mg), intermediate dose ( 7.5 mg) and High Dose (12 mg) Verinurad. As per Protocol Version 5.0, Patients from 3 mg dose will be switched to 24 mg at visit 9; Drug: Allopurinol; Study treatments will be titrated in 3 steps: Low dose (100 mg), intermediate (200 mg) and High Dose ( 300 mg) Allopurinol
Experimental: Allopurinol alone (0/300 mg); Step 1 - titration_0/100 Step 2 - titration_0/200 Step 3 - target dose_0/300	Drug: Allopurinol; Study treatments will be titrated in 3 steps: Low dose (100 mg), intermediate (200 mg) and High Dose ( 300 mg) Allopurinol
Placebo Comparator: Placebo (0/0 mg); Placebo (mg) in 3 steps_0/0	Drug: Placebo for Verinurad; Matching Capsule; Other Names: Placebo; Drug: Placebo for Allopurinol; Matching tablet; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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; PlaceboSubjects that switched from Verinurad 3 mg to Verinurad 24 mg at Visit 9 are not included in this group for Visit 10.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; PlaceboSubjects that switched from Verinurad 3 mg to Verinurad 24 mg at Visit 9 are not included in this group for Visit 10.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; PlaceboSubjects that switched from Verinurad 3 mg to Verinurad 24 mg at Visit 9 are not included in this group for Visit 10.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)

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

General Publications

• Heerspink HJL, Stack AG, Terkeltaub R, Greene TA, Inker LA, Bjursell M, Perl S, Rikte T, Erlandsson F, Perkovic V. Rationale, design, demographics and baseline characteristics of the randomized, controlled, Phase 2b SAPPHIRE study of verinurad plus allopurinol in patients with chronic kidney disease and hyperuricaemia. Nephrol Dial Transplant. 2022 Jul 26;37(8):1461-1471. doi: 10.1093/ndt/gfab237.

Helpful Links

• CSR

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2019
• Primary Completion (Actual): November 22, 2021
• Study Completion (Actual): November 22, 2021

Study Registration Dates

• First Submitted: May 30, 2019
• First Submitted That Met QC Criteria: June 17, 2019
• First Posted (Actual): June 19, 2019

Study Record Updates

• Last Update Posted (Actual): March 2, 2023
• Last Update Submitted That Met QC Criteria: February 1, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Chronic Kidney Disease
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Hyperuricemia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites; Protective Agents; Antioxidants; Free Radical Scavengers; Gout Suppressants; Allopurinol; Verinurad
• Other Study ID Numbers: D5495C00002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool.

Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access.

For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No