Study Stopped
The event rate observed in the study continued to be below primary assumptions, so that the completion of the study within a reasonable timeframe was deemed very unlikely.
Effect of Sodium Zirconium Cyclosilicate on Arrythmia-related Cardiovascular Outcomes in Participants on Chronic Hemodialysis With Recurrent Hyperkalemia (DIALIZE-Outcomes)
An International, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on Arrythmia-related Cardiovascular Outcomes in Participants on Chronic Hemodialysis With Recurrent Hyperkalemia (DIALIZE-Outcomes)
2 other identifiers
interventional
2,690
26 countries
340
Brief Summary
The purpose of this study is to evaluate the effect of Sodium Zirconium Cyclosilicate (SZC) on arrhythmia-related cardiovascular outcomes in participants on chronic hemodialysis with recurrent hyperkalemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2021
Typical duration for phase_3
340 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 8, 2021
CompletedFirst Posted
Study publicly available on registry
April 19, 2021
CompletedStudy Start
First participant enrolled
April 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 7, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 7, 2024
CompletedResults Posted
Study results publicly available
June 18, 2025
CompletedJune 18, 2025
June 1, 2025
2.9 years
April 8, 2021
March 5, 2025
June 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of the Composite of Cardiac Event Outcomes
Incidence of the composite endpoint of SCD, all stroke, or hospitalization/intervention/emergency department (ED) visit due to arrhythmias is analyzed based on Cox regression model with treatment and region as covariates. Patients with no events are censored at final clinical assessment, death, or disposition event.
From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase)
Secondary Outcomes (2)
Normokalemia at 12 Months Post-randomization
Randomization to 12-Month Visit
Incidence of the Composite of Arrhythmia Related Events
From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase)
Study Arms (2)
Sodium Zirconium Cyclosilicate
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Powder for oral suspension in a sachet. A dose is titrated in 5 g increments during a period of 4 weeks from 5 g up to 15 g qd on non-dialysis days. Afterward, the dose is adjusted monthly (or more frequent based on clinical judgment) depending on the current potassium value as measured after the long interdialytic interval (LIDI).
Powder for oral suspension in a sachet. A dose is titrated in 5 g increments during a period of 4 weeks from 5 g up to 15 g qd on non-dialysis days. Afterward, the dose is adjusted monthly (or more frequent based on clinical judgment) depending on the current potassium value as measured after the LIDI.
Eligibility Criteria
You may qualify if:
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
- Provision of signed and dated, written ICF prior to any mandatory study specific procedures, sampling, and analyses
- Must be ≥ 18 years of age, at the time of signing the ICF.
- Receiving hemodialysis (or hemodiafiltration) 3 times a week for treatment of ESRD for ≥ 4 months before enrollment
- Must have hemodialysis access consisting of an arteriovenous fistula, arteriovenous graft, or tunneled (permanent) catheter which is expected to remain in place for the entire duration of the study
- At least 2 out of 3 pre-dialysis S K ≥ 5.5 mmol/L after the LIDI during screening
- Negative pregnancy test for female participants of childbearing potential
- Female participants must be 1 year postmenopausal, surgically sterile, or using one highly effective form of birth control (defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly). They should have been stable on their chosen method of birth control for a minimum of 3 months before entering the study and willing to remain on the birth control until 12 weeks after the last dose
You may not qualify if:
- Pseudohyperkalemia secondary to hemolyzed blood specimen (this situation is not considered screening failure, sampling or full screening can be postponed to a later time as applicable)
- Presence of cardiac arrhythmias or conduction defects that require immediate treatment
- Participants who have a pacemaker or implantable cardiac defibrillator
- Any medical condition, including active, clinically significant infection or liver disease, that in the opinion of the investigator or sponsor may pose a safety risk to a participant in this study, confound safety or efficacy assessment and jeopardize the quality of the data, or interfere with study participation, or any other restrictions or contraindications in the local prescribing information for SZC
- History of QT prolongation associated with other medications that required discontinuation of that medication
- Congenital long QT syndrome
- QTcF \> 550 msec
- Atrial fibrillation requiring immediate/urgent intervention at screening or randomizations
- Treated with sodium polystyrene sulfonate (SPS, Kayexalate, Resonium), calcium polystyrene sulfonate (CPS Resonium Calcium), patiromer (Veltassa), or SZC (Lokelma) within 7 days before screening or anticipated requiring chronic use of any of these agents during the study. If participant requires rescue therapy (potassium binder or dialysate S-K change during screening period), the participant will be screen failed
- Participation in another clinical study with an investigational product, device, or non-standard hemodialysis procedure administered within one month before screening
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
- Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements
- Previous randomization in the present study
- Females who are pregnant (confirmed with positive pregnancy test or a uterine ultrasound if pregnancy test result is questionable), breastfeeding, or planning to become pregnant during the study
- Known hypersensitivity or previous anaphylaxis to SZC or to components thereof
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (340)
Research Site
Huntsville, Alabama, 35805, United States
Research Site
Mesa, Arizona, 85210, United States
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Bakersfield, California, 93309, United States
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Glendale, California, 91206, United States
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Granada Hills, California, 91344, United States
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Lynwood, California, 90262, United States
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San Diego, California, 92111, United States
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Vacaville, California, 95687, United States
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Victorville, California, 92394, United States
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Denver, Colorado, 80210, United States
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Bloomfield, Connecticut, 06002, United States
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Middlebury, Connecticut, 06762, United States
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Newark, Delaware, 19713, United States
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Fort Lauderdale, Florida, 33308, United States
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Tampa, Florida, 33603, United States
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Columbus, Georgia, 31904, United States
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Lawrenceville, Georgia, 30046, United States
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Statesboro, Georgia, 30458, United States
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Nampa, Idaho, 83687, United States
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Iowa City, Iowa, 52242, United States
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Baton Rouge, Louisiana, 70815, United States
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Detroit, Michigan, 48202-2689, United States
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Kalamazoo, Michigan, 49007, United States
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Roseville, Michigan, 48066, United States
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Minneapolis, Minnesota, 55435, United States
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Brookhaven, Mississippi, 39601, United States
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Columbus, Mississippi, 39705, United States
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Tupelo, Mississippi, 38801, United States
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Kansas City, Missouri, 64111, United States
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St Louis, Missouri, 63110, United States
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St Louis, Missouri, 63117, United States
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Las Vegas, Nevada, 89106, United States
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Las Vegas, Nevada, 89128, United States
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Jersey City, New Jersey, 07305, United States
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Manhasset, New York, 11030, United States
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The Bronx, New York, 10461, United States
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Charlotte, North Carolina, 28208, United States
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New Bern, North Carolina, 28562, United States
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Winston-Salem, North Carolina, 27103, United States
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Bethlehem, Pennsylvania, 18017, United States
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Providence, Rhode Island, 02903, United States
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Spartanburg, South Carolina, 29306, United States
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Austin, Texas, 78751, United States
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Austin, Texas, 78758, United States
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Conroe, Texas, 77384, United States
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El Paso, Texas, 79925, United States
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El Paso, Texas, 79935, United States
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Greenville, Texas, 75402, United States
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Houston, Texas, 77054, United States
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Houston, Texas, 77090, United States
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San Antonio, Texas, 78229, United States
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San Antonio, Texas, 78251, United States
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San Antonio, Texas, 78258, United States
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St. George, Utah, 84770, United States
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Norfolk, Virginia, 23502, United States
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Virginia Beach, Virginia, 23454, United States
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Milwaukee, Wisconsin, 53226, United States
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Córdoba, X5016LIG, Argentina
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Junín, 6000, Argentina
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Mar del Plata, B7600DBZ, Argentina
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Pergamino, B2700LDK, Argentina
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San Luis, 5700, Argentina
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San Luis, D5700CTA, Argentina
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Santa Rosa, L6300, Argentina
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Sarandí, B1872EEC, Argentina
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Graz, 8036, Austria
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Innsbruck, 6020, Austria
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Brasília, 70390-700, Brazil
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Curitiba, 80230-130, Brazil
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Curitiba, 80440-020, Brazil
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Joinville, 89227-680, Brazil
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Maringá, 87060-040, Brazil
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Porto Alegre, 90020-090, Brazil
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Porto Alegre, 90160-093, Brazil
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Recife, 50720-635, Brazil
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Ribeirão Preto, 14025-170, Brazil
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Rio de Janeiro, 20551-030, Brazil
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São Paulo, 04038-031, Brazil
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São Paulo, 05024-040, Brazil
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São Paulo, 05403-9000, Brazil
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Blagoevgrad, 2700, Bulgaria
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Gotse Delchev, 2900, Bulgaria
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Haskovo, 6300, Bulgaria
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Pleven, 5800, Bulgaria
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Plovdiv, 4000, Bulgaria
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Razlog, 2760, Bulgaria
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Samokov, 2000, Bulgaria
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Sandanski, 2800, Bulgaria
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Silistra, 7500, Bulgaria
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Smolyan, 3700, Bulgaria
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Sofia, 1606, Bulgaria
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Stara Zagora, 6000, Bulgaria
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Varna, 9010, Bulgaria
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Yambol, 8600, Bulgaria
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Saint John, New Brunswick, E2L 4L2, Canada
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Halifax, Nova Scotia, B3H 2Y9, Canada
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Sydney, Nova Scotia, B1P 1P3, Canada
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Oshawa, Ontario, L1G 2B9, Canada
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Toronto, Ontario, M3M 0B2, Canada
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Greenfield Park, Quebec, J4V 2H1, Canada
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Montreal, Quebec, H1T 2M4, Canada
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Montreal, Quebec, H2T 3B3, Canada
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Montreal, Quebec, H3T 1E4, Canada
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Montreal, Quebec, H4J 1C5, Canada
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Québec, Quebec, G1R 2J6, Canada
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Beijing, 100029, China
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Beijing, 100034, China
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Beijing, 100191, China
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Changchun, 130021, China
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Changsha, 410004, China
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Changsha, 410008, China
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Changsha, 410013, China
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Changsha, 430033, China
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Changzhou, 213000, China
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Chengdu, 610000, China
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Chengdu, 610500, China
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Dongguan, 523009, China
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Foshan, 528000, China
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Fuzhou, 350001, China
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Guangzhou, 510000, China
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Guangzhou, 510080, China
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Guangzhou, 510630, China
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Guangzhou, 510800, China
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Guangzhou, 511400, China
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Guilin, 541000, China
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Guiyang, 550002, China
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Guiyang, 550004, China
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Haikou, 570311, China
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Hangzhou, 310014, China
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Hefei, 230601, China
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Hohhot, 10050, China
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Huai'an, 223300, China
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Jinan, 250031, China
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Jinhua, 322100, China
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Jiujiang, 332000, China
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Kunming, 650032, China
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Lanzhou, 730000, China
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Lanzhou, 730030, China
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Nanchang, 330006, China
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Nanjing, 210009, China
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Nanjing, 210029, China
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Nanyang, 473000, China
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Ningbo, 315010, China
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Panjin, 124009, China
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Pingxiang, 337055, China
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Qingdao, 266011, China
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Shanghai, 200240, China
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Shanghai, 201199, China
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Shanghai, 201200, China
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Shengyang, 110004, China
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Shenzhen, 518020, China
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Siping, 136000, China
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Taian, 271099, China
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Taiyuan, 030012, China
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Tianjin, 300121, China
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Tianjin, 300192, China
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Ürümqi, CN-830004, China
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Wenzhou, 325027, China
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Wuhan, 430010, China
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Wuhan, 430022, China
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Wuhu, 241000, China
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Wuxi, 214023, China
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Xiamen, 361004, China
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Xianyang, 712000, China
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Yibin, 644000, China
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Yinchuan, 750004, China
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Zhengzhou, 450052, China
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Zhuzhou, 412007, China
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České Budějovice, 370 01, Czechia
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Havlíčkův Brod, 580 22, Czechia
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Jilemnice, 514 01, Czechia
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Klatovy, 339 01, Czechia
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Liberec, 460 63, Czechia
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Nové Město na Moravě, 692 31, Czechia
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Pilsen, 32300, Czechia
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Prague, 140 21, Czechia
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Tábor, 390 03, Czechia
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Třebíč, 674 01, Czechia
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Cloppenburg, 49661, Germany
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Düsseldorf, 40210, Germany
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Hanover, 30625, Germany
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Minden, 32429, Germany
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Potsdam, 14467, Germany
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Stuttgart, 70376, Germany
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Villingen-Schwenningen, 78052, Germany
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Baja, 6500, Hungary
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Budapest, 1083, Hungary
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Kaposvár, 7400, Hungary
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Karcag, 5300, Hungary
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Kistarcsa, 2143, Hungary
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Miskolc, 3526, Hungary
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Nagykanizsa, 8800, Hungary
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Szombathely, 9700, Hungary
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Ahmedabad, 380054, India
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Chennai, 600037, India
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Dhanvantari Nagar, 605006, India
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Nadiād, 387001, India
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Pune, 411013, India
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Bassano del Grappa, 36061, Italy
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Bergamo, 24127, Italy
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Bologna, 40138, Italy
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Caserta, 81100, Italy
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Milan, 20132, Italy
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Monza, 20052, Italy
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Parma, 43100, Italy
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Pavia, 27100, Italy
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Pesaro, 61121, Italy
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Roma, 00168, Italy
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San Giovanni Rotondo, 71013, Italy
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Verona, 37124, Italy
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Fujisawa-shi, 251-0041, Japan
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Fukuoka, 810-0004, Japan
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Hamamatsu, 434-0018, Japan
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Kawasaki-shi, 210-0852, Japan
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Kumagaya-shi, 360-0831, Japan
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Kumamoto, 861-8520, Japan
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Kyoto, 600-8216, Japan
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Moriya-shi, 3020118, Japan
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Nagano, 380-0904, Japan
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Nagasaki, 852-8053, Japan
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Nakagami-gun, 901-2393, Japan
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Okinawa-shi, 904-2143, Japan
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Ōmihachiman, 523-0082, Japan
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Sashima-gun, 306-0433, Japan
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Setagaya-ku, 158-0094, Japan
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Shiroishi-shi, 989-0231, Japan
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Tamanashi, 865-0016, Japan
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Toride-shi, 302-0011, Japan
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Tsuchiura-shi, 300-0062, Japan
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Tsuchiura-shi, 300-0835, Japan
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Tsukuba, 305-0861, Japan
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Ushiku-shi, 300-1296, Japan
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Yatomi-shi, 498-0006, Japan
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Batu Caves, 68100, Malaysia
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Ipoh, 30990, Malaysia
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Malacca, 75400, Malaysia
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Seri Manjung, 32040, Malaysia
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Chihuahua City, 31203, Mexico
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Culiacán, 80230, Mexico
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D.F, 14000, Mexico
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Mazatlán, 82000, Mexico
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Mexico City, 0 3100, Mexico
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Monterrey, 64610, Mexico
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Morelia, 58260, Mexico
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San Luis Potosí City, 78250, Mexico
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Veracruz, 91900, Mexico
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Xalapa, 91020, Mexico
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Zapopan, 45138, Mexico
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Cusco, CUSCO 01, Peru
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Lima, 14, Peru
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Lima, 15036, Peru
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Lima, 15046, Peru
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Lima, 15088, Peru
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Lima, LIMA 01, Peru
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Piura, 20001, Peru
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Gdansk, 80-462, Poland
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Leżajsk, 37-300, Poland
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Lodz, 90-153, Poland
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Lodz, 92-213, Poland
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Lublin, 20-954, Poland
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Oleśnica, 56-400, Poland
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Olkusz, 32-300, Poland
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Pszczyna, 43-200, Poland
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Słupsk, 76-200, Poland
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Tczew, 83-110, Poland
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Wołomin, 05-200, Poland
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Wroclaw, 50-981, Poland
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Żory, 44-240, Poland
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Żyrardów, 96-300, Poland
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Kemerovo, 650000, Russia
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Mytischi, 141009, Russia
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Novosibirsk, 630087, Russia
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Omsk, 644112, Russia
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Penza, 440034, Russia
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Saint Petersburg, 190103, Russia
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Saint Petersburg, 191167, Russia
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Yaroslavl, 150062, Russia
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Bratislava, 85107, Slovakia
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Komárno, 945 75, Slovakia
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Košice, 04011, Slovakia
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Lučenec, 984 01, Slovakia
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Púchov, 2001, Slovakia
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Žilina, 010 01, Slovakia
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Alcalá de Henares, 28805, Spain
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Barcelona, 08025, Spain
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Córdoba, 14004, Spain
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Madrid, 28006, Spain
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Madrid, 28007, Spain
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Madrid, 28031, Spain
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Pamplona, 31008, Spain
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Valencia, 46017, Spain
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Kaohsiung City, Taiwan
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Keelung, 20448, Taiwan
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Linkou District, 244, Taiwan
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New Taipei City, 220, Taiwan
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New Taipei City, 23561, Taiwan
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Taichung, 40705, Taiwan
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Taipei, 100, Taiwan
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Taipei, 110, Taiwan
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Taipei, 114, Taiwan
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Bangkok, 10330, Thailand
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Chiang Mai, 50200, Thailand
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Hat Yai, 90110, Thailand
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Ratchathewi, 10400, Thailand
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Adapazarı, 54100, Turkey (Türkiye)
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Ankara, 06800, Turkey (Türkiye)
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Gaziantep, 27310, Turkey (Türkiye)
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Kahramanmaraş, 46100, Turkey (Türkiye)
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Kayseri, 38039, Turkey (Türkiye)
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Kocaeli, 41380, Turkey (Türkiye)
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Chernivtsі, 58001, Ukraine
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Dnipro, 49005, Ukraine
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Ivano-Frankivsk, 78018, Ukraine
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Kyiv, 01004, Ukraine
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Kyiv, 02125, Ukraine
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Kyiv, 03680, Ukraine
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Kyiv, 04107, Ukraine
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Odesa, 65074, Ukraine
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Ternopil, 46001, Ukraine
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Uzhhorod, 88018, Ukraine
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Vinnytsia, 21018, Ukraine
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Zaporizhzhia, 69001, Ukraine
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Zaporizhzhia, 69600, Ukraine
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Bristol, BS105NB, United Kingdom
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Leicester, LE5 4PW, United Kingdom
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Liverpool, L9 7AL, United Kingdom
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London, E1 1BB, United Kingdom
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London, SE1 2PR, United Kingdom
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Preston, PR2 9HT, United Kingdom
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Salford, M6 8HD, United Kingdom
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Swansea, SN6 6NL, United Kingdom
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Wolverhampton, WV10 OQP, United Kingdom
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Biên Hòa, 810000, Vietnam
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Da Nang, 55000, Vietnam
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Hanoi, 100000, Vietnam
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Hanoi, 10000, Vietnam
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Ho Chi Minh City, 10000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
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Ho Chi Minh City, 70000, Vietnam
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Huế, 530000, Vietnam
Related Publications (2)
Fishbane S, Dember LM, Jadoul M, Kovesdy CP, Guzman N, Kordzakhia G, Lisovskaja V, Sekar P, Wessman P, Al-Shurbaji A, Herzog CA. The randomized DIALIZE-Outcomes trial evaluated sodium zirconium cyclosilicate in hemodialysis. Kidney Int. 2025 Oct;108(4):686-694. doi: 10.1016/j.kint.2025.06.016. Epub 2025 Jul 4.
PMID: 40618849DERIVEDFishbane S, Jadoul M, Dember L, Kovesdy CP, Al-Shurbaji A, Lisovskaja V, Sekar P, Katona B, Guzman N, Herzog C. Evaluation of the effect of sodium zirconium cyclosilicate on arrhythmia-related cardiovascular outcomes in patients receiving chronic haemodialysis with hyperkalaemia: protocol for the multicentre, randomised, controlled DIALIZE-Outcomes study. BMJ Open. 2023 May 25;13(5):e071309. doi: 10.1136/bmjopen-2022-071309.
PMID: 37230521DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Study was terminated early due to lower-than-expected primary event rate and higher than anticipated drop-out rate. Lower number of evaluable events reduces the precision of the primary analysis considerably.
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Steven Fishbane, Professor, MD
North Shore University Hospital, 300 Community Drive, Manhasset, NY 11030
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2021
First Posted
April 19, 2021
Study Start
April 30, 2021
Primary Completion
March 7, 2024
Study Completion
March 7, 2024
Last Updated
June 18, 2025
Results First Posted
June 18, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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
- 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
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.