HyperkalemiaPhase 3NCT04847232
Effect of Sodium Zirconium Cyclosilicate on Arrythmia-related Cardiovascular Outcomes in Participants on Chronic Hemodialysis With Recurrent Hyperkalemia (DIALIZE-Outcomes)
A Phase 3 study testing Sodium Zirconium Cyclosilicate (SZC) in people with Hyperkalemia, run by AstraZeneca at 340 sites in 26 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Hyperkalemia
- What is being tested?
- Sodium Zirconium Cyclosilicate (SZC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,690 participants
- Where
- 340 sitesin 26 countries
- Study dates
- 30 Apr 2021to 7 Mar 2024
- Phase
- Phase 3
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 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
- Scheduled date for living donor kidney transplant
- Sustained Ventricular Tachycardia > 30 seconds requiring assessment / intervention
Trial locations and contacts
340 sites in 26 countries.
340 sites in 26 countries
China63 sites
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Beijing, 100029
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Beijing, 100034
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Beijing, 100191
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Changchun, 130021
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Changsha, 410004
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Changsha, 410008
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Changsha, 410013
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Changsha, 430033
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Changzhou, 213000
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Chengdu, 610000
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Chengdu, 610500
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Dongguan, 523009
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Foshan, 528000
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Fuzhou, 350001
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Guangzhou, 510000
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Guangzhou, 510080
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Guangzhou, 510630
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Guangzhou, 510800
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Guangzhou, 511400
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Guilin, 541000
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Guiyang, 550002
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Guiyang, 550004
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Haikou, 570311
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Hangzhou, 310014
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Hefei, 230601
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Hohhot, 10050
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Huai'an, 223300
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Jinan, 250031
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Jinhua, 322100
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Jiujiang, 332000
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Kunming, 650032
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Lanzhou, 730000
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Lanzhou, 730030
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Nanchang, 330006
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Nanjing, 210009
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Nanjing, 210029
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Nanyang, 473000
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Ningbo, 315010
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Panjin, 124009
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Pingxiang, 337055
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Qingdao, 266011
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Shanghai, 200240
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Shanghai, 201199
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Shanghai, 201200
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Shengyang, 110004
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Shenzhen, 518020
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Siping, 136000
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Taian, 271099
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Taiyuan, 030012
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Tianjin, 300121
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Tianjin, 300192
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Ürümqi, CN-830004
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Wenzhou, 325027
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Wuhan, 430010
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Wuhan, 430022
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Wuhu, 241000
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Wuxi, 214023
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Xiamen, 361004
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Xianyang, 712000
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Yibin, 644000
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Yinchuan, 750004
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Zhengzhou, 450052
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Zhuzhou, 412007
United States57 sites
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Austin, Texas, 78751
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Austin, Texas, 78758
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Bakersfield, California, 93309
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Baton Rouge, Louisiana, 70815
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Bethlehem, Pennsylvania, 18017
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Bloomfield, Connecticut, 06002
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Brookhaven, Mississippi, 39601
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Charlotte, North Carolina, 28208
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Columbus, Georgia, 31904
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Columbus, Mississippi, 39705
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Conroe, Texas, 77384
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Denver, Colorado, 80210
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Detroit, Michigan, 48202-2689
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El Paso, Texas, 79925
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El Paso, Texas, 79935
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Fort Lauderdale, Florida, 33308
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Glendale, California, 91206
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Granada Hills, California, 91344
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Greenville, Texas, 75402
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Houston, Texas, 77054
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Houston, Texas, 77090
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Huntsville, Alabama, 35805
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Iowa City, Iowa, 52242
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Jersey City, New Jersey, 07305
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Kalamazoo, Michigan, 49007
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Kansas City, Missouri, 64111
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Las Vegas, Nevada, 89106
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Las Vegas, Nevada, 89128
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Lawrenceville, Georgia, 30046
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Lynwood, California, 90262
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Manhasset, New York, 11030
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Mesa, Arizona, 85210
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Middlebury, Connecticut, 06762
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Milwaukee, Wisconsin, 53226
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Minneapolis, Minnesota, 55435
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Nampa, Idaho, 83687
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New Bern, North Carolina, 28562
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Newark, Delaware, 19713
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Norfolk, Virginia, 23502
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Providence, Rhode Island, 02903
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Roseville, Michigan, 48066
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San Antonio, Texas, 78229
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San Antonio, Texas, 78251
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San Antonio, Texas, 78258
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San Diego, California, 92111
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Spartanburg, South Carolina, 29306
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St Louis, Missouri, 63110
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St Louis, Missouri, 63117
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St. George, Utah, 84770
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Statesboro, Georgia, 30458
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Tampa, Florida, 33603
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The Bronx, New York, 10461
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Tupelo, Mississippi, 38801
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Vacaville, California, 95687
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Victorville, California, 92394
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Virginia Beach, Virginia, 23454
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Winston-Salem, North Carolina, 27103
Japan23 sites
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Fujisawa-shi, 251-0041
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Fukuoka, 810-0004
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Hamamatsu, 434-0018
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Kawasaki-shi, 210-0852
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Kumagaya-shi, 360-0831
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Kumamoto, 861-8520
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Kyoto, 600-8216
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Moriya-shi, 3020118
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Nagano, 380-0904
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Nagasaki, 852-8053
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Nakagami-gun, 901-2393
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Okinawa-shi, 904-2143
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Ōmihachiman, 523-0082
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Sashima-gun, 306-0433
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Setagaya-ku, 158-0094
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Shiroishi-shi, 989-0231
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Tamanashi, 865-0016
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Toride-shi, 302-0011
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Tsuchiura-shi, 300-0062
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Tsuchiura-shi, 300-0835
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Tsukuba, 305-0861
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Ushiku-shi, 300-1296
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Yatomi-shi, 498-0006
Bulgaria14 sites
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Blagoevgrad, 2700
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Gotse Delchev, 2900
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Haskovo, 6300
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Pleven, 5800
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Plovdiv, 4000
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Razlog, 2760
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Samokov, 2000
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Sandanski, 2800
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Silistra, 7500
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Smolyan, 3700
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Sofia, 1606
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Stara Zagora, 6000
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Varna, 9010
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Yambol, 8600
Poland14 sites
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Gdansk, 80-462
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Leżajsk, 37-300
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Lodz, 90-153
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Lodz, 92-213
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Lublin, 20-954
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Oleśnica, 56-400
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Olkusz, 32-300
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Pszczyna, 43-200
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Słupsk, 76-200
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Tczew, 83-110
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Wołomin, 05-200
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Wroclaw, 50-981
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Żory, 44-240
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Żyrardów, 96-300
Brazil13 sites
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Brasília, 70390-700
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Curitiba, 80230-130
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Curitiba, 80440-020
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Joinville, 89227-680
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Maringá, 87060-040
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Porto Alegre, 90020-090
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Porto Alegre, 90160-093
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Recife, 50720-635
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Ribeirão Preto, 14025-170
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Rio de Janeiro, 20551-030
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São Paulo, 04038-031
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São Paulo, 05024-040
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São Paulo, 05403-9000
Ukraine13 sites
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Chernivtsі, 58001
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Dnipro, 49005
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Ivano-Frankivsk, 78018
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Kyiv, 01004
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Kyiv, 02125
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Kyiv, 03680
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Kyiv, 04107
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Odesa, 65074
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Ternopil, 46001
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Uzhhorod, 88018
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Vinnytsia, 21018
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Zaporizhzhya, 69001
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Zaporizhzhya, 69600
Italy12 sites
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Bassano del Grappa, 36061
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Bergamo, 24127
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Bologna, 40138
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Caserta, 81100
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Milan, 20132
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Monza, 20052
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Parma, 43100
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Pavia, 27100
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Pesaro, 61121
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Roma, 00168
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San Giovanni Rotondo, 71013
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Verona, 37124
Canada11 sites
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Greenfield Park, Quebec, J4V 2H1
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Halifax, Nova Scotia, B3H 2Y9
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Montreal, Quebec, H1T 2M4
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Montreal, Quebec, H2T 3B3
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Montreal, Quebec, H3T 1E4
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Montreal, Quebec, H4J 1C5
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Oshawa, Ontario, L1G 2B9
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Québec, Quebec, G1R 2J6
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Saint John, New Brunswick, E2L 4L2
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Sydney, Nova Scotia, B1P 1P3
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Toronto, Ontario, M3M 0B2
Mexico11 sites
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Chihuahua City, 31203
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Culiacán, 80230
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D.F, 14000
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Mazatlán, 82000
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Mexico City, 0 3100
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Monterrey, 64610
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Morelia, 58260
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San Luis Potosí City, 78250
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Veracruz, 91900
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Xalapa, 91020
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Zapopan, 45138
Czechia10 sites
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České Budějovice, 370 01
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Havlíčkův Brod, 580 22
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Jilemnice, 514 01
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Klatovy, 339 01
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Liberec, 460 63
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Nové Město na Moravě, 692 31
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Pilsen, 32300
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Prague, 140 21
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Tábor, 390 03
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Třebíč, 674 01
Taiwan9 sites
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Kaohsiung City
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Keelung, 20448
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Linkou District, 244
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New Taipei City, 220
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New Taipei City, 23561
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Taichung, 40705
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Taipei, 100
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Taipei, 110
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Taipei, 114
United Kingdom9 sites
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Bristol, BS105NB
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Leicester, LE5 4PW
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Liverpool, L9 7AL
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London, E1 1BB
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London, SE1 2PR
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Preston, PR2 9HT
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Salford, M6 8HD
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Swansea, SN6 6NL
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Wolverhampton, WV10 OQP
Argentina8 sites
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Córdoba, X5016LIG
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Junín, 6000
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Mar del Plata, B7600DBZ
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Pergamino, B2700LDK
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San Luis, 5700
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San Luis, D5700CTA
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Santa Rosa, L6300
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Sarandí, B1872EEC
Hungary8 sites
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Baja, 6500
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Budapest, 1083
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Kaposvár, 7400
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Karcag, 5300
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Kistarcsa, 2143
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Miskolc, 3526
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Nagykanizsa, 8800
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Szombathely, 9700
Russia8 sites
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Kemerovo, 650000
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Mytischi, 141009
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Novosibirsk, 630087
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Omsk, 644112
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Penza, 440034
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Saint Petersburg, 190103
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Saint Petersburg, 191167
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Yaroslavl, 150062
Spain8 sites
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Alcalá de Henares, 28805
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Barcelona, 08025
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Córdoba, 14004
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Madrid, 28006
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Madrid, 28007
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Madrid, 28031
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Pamplona, 31008
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Valencia, 46017
Vietnam8 sites
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Bien Hoa, 810000
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Da Nang, 55000
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Hanoi, 100000
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Hanoi, 10000
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Ho Chi Minh City, 10000
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Ho Chi Minh City, 700000
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Ho Chi Minh City, 70000
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Huế, 530000
Germany7 sites
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Cloppenburg, 49661
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Düsseldorf, 40210
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Hanover, 30625
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Minden, 32429
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Potsdam, 14467
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Stuttgart, 70376
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Villingen-Schwenningen, 78052
Peru7 sites
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Cusco, CUSCO 01
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Lima, 14
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Lima, 15036
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Lima, 15046
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Lima, 15088
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Lima, LIMA 01
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Piura, 20001
Slovakia6 sites
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Bratislava, 85107
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Komárno, 945 75
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Košice, 04011
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Lučenec, 984 01
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Púchov, 2001
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Žilina, 010 01
Turkey (Türkiye)6 sites
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Adapazarı, 54100
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Ankara, 06800
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Gaziantep, 27310
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Kahramanmaraş, 46100
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Kayseri, 38039
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Kocaeli, 41380
India5 sites
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Ahmedabad, 380054
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Chennai, 600037
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Dhanvantari Nagar, 605006
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Nadiād, 387001
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Pune, 411013
Malaysia4 sites
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Batu Caves, 68100
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Ipoh, 30990
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Malacca, 75400
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Seri Manjung, 32040
Thailand4 sites
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Bangkok, 10330
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Chiang Mai, 50200
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Hat Yai, 90110
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Ratchathewi, 10400
About this study
Official title: 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)
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.
Read the detailed description
This is an international, multicenter, event-driven, randomized, double-blind, parallel group, placebo-controlled study, evaluating the utility of SZC versus placebo to reduce the incidence of sudden cardiac death (SCD), stroke, and arrhythmia-related hospitalizations, interventions, and emergency department (ED) visits in participants on chronic hemodialysis with recurrent hyperkalemia.
- Conditions
- Hyperkalemia
- Being tested
- Sodium Zirconium Cyclosilicate (SZC), SZC Placebo
- Keywords
- Hemodialysis, Hyperkalemia, Cardiovascular Events, Atrial Fibrillation, Ventricular Tachycardia
- Medical subject headings
- Hyperkalemia, Atrial Fibrillation, Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Zirconium Cyclosilicate (SZC)Drug
Also called Lokelma TM
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).
SZC PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Sodium Zirconium Cyclosilicate | Experimental | Not described Receives: Drug: Sodium Zirconium Cyclosilicate (SZC) |
| Placebo | Placebo comparator | Not described Receives: Drug: SZC Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase)
Secondary outcomes (2)
Normokalemia at 12 Months Post-randomization
Logistic regression analysis of whether a subject is Normokalemic (S-K of 4.0 - 5.5 mmol/L ) after the LIDI at the 12-month visit.
Measured: Randomization to 12-Month Visit
Incidence of the Composite of Arrhythmia Related Events
Incidence of the composite endpoint of 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.
Measured: From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start30 Apr 2021
- Primary completion7 Mar 2024
- Study completion7 Mar 2024
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HyperkalemiaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,690 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Fishbane, Professor, MD, Principal investigator, North Shore University Hospital, 300 Community Drive, Manhasset, NY 11030
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04847232
- Sponsor's protocol ID
- D9487C00001
- Other IDs
- 2020-005561-14
- Status last verified
- Jun 2025
- First submitted
- 8 Apr 2021
- Last updated
- 18 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 40618849Fishbane 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.
PubMed 37230521