Intensive Uric Acid Lowering With Verinurad and Febuxostat in Patients With Albuminuria
Effects of Intensive Uric Acid Lowering Therapy With RDEA3170 (Verinurad) and Febuxostat in Patients With Albuminuria
1 other identifier
interventional
60
1 country
18
Brief Summary
The purpose of this clinical research study is to evaluate signals of potential clinical benefit of the combination of Verinurad and Febuxostat in lowering concentrations of circulating uric acid and thus improving kidney or cardiovascular status of patients with hyperuricemia, albuminuria, and Type 2 diabetes (T2DM).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2017
Shorter than P25 for phase_2
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2017
CompletedFirst Posted
Study publicly available on registry
April 18, 2017
CompletedStudy Start
First participant enrolled
May 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 13, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 13, 2018
CompletedResults Posted
Study results publicly available
January 10, 2020
CompletedJanuary 10, 2020
December 1, 2019
1.2 years
April 12, 2017
July 15, 2019
December 18, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
Urinary Albumin to Creatinine Ratio (UACR)
LS Mean Percentage Change (95% CI) from Baseline in UACR
From Baseline to 12 Weeks of Treatment
Urinary Albumin to Creatinine Ratio (UACR) Compared to Placebo
LS Mean Percentage Change (90% CI) from Baseline in UACR Compared to Placebo
From Baseline to 24 Weeks of Treatment
Urinary Albumin to Creatinine Ratio (UACR)
LS Mean Percentage Change (95% CI) from Baseline in UACR
From Baseline to 24 Weeks of Treatment
Secondary Outcomes (12)
sUA
From Baseline to 12 Weeks and 24 Weeks of Treatment
eGFR
From Baseline to 12 Weeks and 24 Weeks of Treatment
Serum Creatinine
From Baseline to 12 Weeks and 24 Weeks of Treatment
Serum Cystatin C
From Baseline to 12 Weeks and 24 Weeks of Treatment
Serum High Sensitivity C-reactive Protein
From Baseline to 12 Weeks and 24 Weeks of Treatment
- +7 more secondary outcomes
Other Outcomes (26)
Flow Mediated Dilatation (Reactive Hyperemia)
From Baseline to 12 Weeks and 24 Weeks of Treatment
Urinalysis
From Baseline to 12 Weeks and 24 Weeks of Treatment
Clinical Chemistry Values
From Baseline to 12 Weeks and 24 Weeks of Treatment
- +23 more other outcomes
Study Arms (2)
Verinurad 9 mg+Febuxostat 80 mg
EXPERIMENTALCapsule administered orally, once daily for 24 weeks
Placebo
PLACEBO COMPARATORCapsule administered orally, once daily for 24 weeks
Interventions
Capsule administered orally, once daily for 24 weeks
Eligibility Criteria
You may qualify if:
- Serum Uric Acid ≥6.0 mg/dL
- eGFR ≥30 mL/min/1.73 m2
- UACR between 30 mg/g and 3500 mg/g inclusive
- Diagnosed with T2DM
You may not qualify if:
- Treated with any drug for hyperuricemia in the 6 months preceding randomization.Drugs for hyperuricemia include all XO inhibitors (allopurinol, febuxostat and topiroxostat) and URAT1 inhibitors (lesinurad, verinurad, probenecid, and benzbromarone)
- Prior history of gout, unless prophylaxis therapy isn't required
- Patients who are pregnant, lactating, or planning to become pregnant
- Patients unsuitable or unable to undergo MRI assessment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (18)
Research Site
Canyon Country, California, 91351, United States
Research Site
Chula Vista, California, 91911, United States
Research Site
Corona, California, 92882, United States
Research Site
Escondido, California, 92025, United States
Research Site
Lakewood, California, 90805, United States
Research Site
Lincoln, California, 95648, United States
Research Site
Los Angeles, California, 90017, United States
Research Site
Los Angeles, California, 90022, United States
Research Site
Los Angeles, California, 90036, United States
Research Site
North Hollywood, California, 91606, United States
Research Site
Oceanside, California, 92056-4510, United States
Research Site
Orange, California, 92868, United States
Research Site
Sacramento, California, 95821, United States
Research Site
Houston, Texas, 77058, United States
Research Site
Houston, Texas, 77070, United States
Research Site
Pearland, Texas, 77584, United States
Research Site
Sugar Land, Texas, 77478, United States
Research Site
Webster, Texas, 77598, United States
Related Publications (2)
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.
PMID: 34383954DERIVEDStack AG, Dronamraju N, Parkinson J, Johansson S, Johnsson E, Erlandsson F, Terkeltaub R. Effect of Intensive Urate Lowering With Combined Verinurad and Febuxostat on Albuminuria in Patients With Type 2 Diabetes: A Randomized Trial. Am J Kidney Dis. 2021 Apr;77(4):481-489. doi: 10.1053/j.ajkd.2020.09.009. Epub 2020 Oct 29.
PMID: 33130235DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The treatment code was broken for 3 patients.The effect of verinurad/febuxostat on sUA was underestimated as drug was administered after collection of blood samples.3 patients treated with verinurad/febuxostat had no detectable drug in PK samples.
Results Point of Contact
- Title
- Fredrik Erlandsson, Global Clinical Lead
- Organization
- AstraZeneca R&D
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Verinurad capsules/matching placebo capsules and febuxostat/matching placebo capsules with randomization code printed on each label
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2017
First Posted
April 18, 2017
Study Start
May 18, 2017
Primary Completion
August 13, 2018
Study Completion
August 13, 2018
Last Updated
January 10, 2020
Results First Posted
January 10, 2020
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share
Individual participant data (IPD) will likely not be shared with external collaborators/researchers as this data is planned to be used only for internal decision-making