Effect of Sodium Zirconium Cyclosilicate on Arrythmia-related Cardiovascular Outcomes in Participants on Chronic Hemodialysis With Recurrent Hyperkalemia (DIALIZE-Outcomes)
Sponsor
AstraZeneca (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04847232
Collaborator
(none)
2,300
329
2
34.7
7
0.2
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
2300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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)
Actual Study Start Date
:
Apr 30, 2021
Anticipated Primary Completion Date
:
Mar 22, 2024
Anticipated Study Completion Date
:
Mar 22, 2024
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sodium Zirconium Cyclosilicate
|
Drug: Sodium Zirconium Cyclosilicate (SZC)
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).
Other Names:
|
| Placebo Comparator: Placebo
|
Drug: SZC Placebo
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.
|
Outcome Measures
Primary Outcome Measures
- Time to first occurrence of SCD, stroke, or hospitalization/intervention/ED visit due to arrhythmias (atrial fibrillation [AF], bradycardia, asystole, ventricular tachyarrhythmia [VF, VT, etc.]) [From randomization visit through study completion during study visits every 3 months, over an average of 2 years]
Secondary Outcome Measures
- S-K of 4.0-5.5 mmol/L (yes/no) after the long interdialytic interval (LIDI) at the 12 month visit [Evaluated at 12 months after randomization]
- Time to first occurrence of hospitalization/intervention/ED visit due to arrhythmias (AF, bradycardia, asystole, Ventricular tachyarrhythmia [VF, VT etc.]) [From randomization visit through study completion during study visits every 3 months, over an average of 2 years]
- Number of hospitalizations/interventions/ED visits due to arrhythmias (AF, bradycardia, asystole, Ventricular tachyarrhythmia [VF, VT etc.]) [From randomization visit through study completion during study visits every 3 months, over an average of 2 years]
- Time to first instance of rescue therapy use for hyperkalemia [From randomization visit through study completion during study visits every 3 months, over an average of 2 years]
- S-K > 6.5 mmol/L (yes/no) after the LIDI at the 12 month visit [Evaluated at 12 months after randomization]
- Time to SCD [From randomization visit through study completion during study visits every 3 months, over an average of 2 years]
- Time to first occurrence of stroke [From randomization visit through study completion during study visits every 3 months, over an average of 2 years]
- Time to cardiovascular (CV) death [From randomization visit through study completion during study visits every 3 months, over an average of 2 years]
- Time to death of any cause [From randomization visit through study completion during study visits every 3 months, over an average of 2 years]
Other Outcome Measures
- Adverse Events (AEs)/ Serious Adverse Events (SAEs) [From randomization/ screening visit through study completion during study visits every 3 months, over an average of 2 years]
- Events of pre-dialysis hypokalemia (S-K < 3.0 mmol/L) [From randomization visit through study completion during study visits every 3 months, over an average of 2 years]
- Change in interdialytic weight gain (kg) as compared to baseline [From randomization visit through study completion during study visits every 3 months, over an average of 2 years]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 130 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
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. For participants < 20 years of age and enrolled in Japan, a written informed consent should be obtained from the participant and his or her legally acceptable representative
-
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
Exclusion Criteria:
-
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 patient requires rescue therapy (potassium binder or dialysate S-K change during screening period), the patient will be screen failed
-
Participation in another clinical study with an investigational product 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Mesa | Arizona | United States | 85210 |
| 2 | Research Site | Bakersfield | California | United States | 93309 |
| 3 | Research Site | Granada Hills | California | United States | 91344 |
| 4 | Research Site | Lynwood | California | United States | 90262 |
| 5 | Research Site | San Diego | California | United States | 92111 |
| 6 | Research Site | Vacaville | California | United States | 95687 |
| 7 | Research Site | Victorville | California | United States | 92394 |
| 8 | Research Site | Denver | Colorado | United States | 80210 |
| 9 | Research Site | Bloomfield | Connecticut | United States | 06002 |
| 10 | Research Site | Middlebury | Connecticut | United States | 06762 |
| 11 | Research Site | Newark | Delaware | United States | 19713 |
| 12 | Research Site | Fort Lauderdale | Florida | United States | 33308 |
| 13 | Research Site | Ocala | Florida | United States | 34471 |
| 14 | Research Site | Tampa | Florida | United States | 33603 |
| 15 | Research Site | Columbus | Georgia | United States | 31904 |
| 16 | Research Site | Lawrenceville | Georgia | United States | 30046 |
| 17 | Research Site | Nampa | Idaho | United States | 83687 |
| 18 | Research Site | Iowa City | Iowa | United States | 52242 |
| 19 | Research Site | Detroit | Michigan | United States | 48202-2689 |
| 20 | Research Site | Pontiac | Michigan | United States | 48341 |
| 21 | Research Site | Minneapolis | Minnesota | United States | 55435 |
| 22 | Research Site | Brookhaven | Mississippi | United States | 39601 |
| 23 | Research Site | Columbus | Mississippi | United States | 39705 |
| 24 | Research Site | Tupelo | Mississippi | United States | 38801 |
| 25 | Research Site | Kansas City | Missouri | United States | 64111 |
| 26 | Research Site | Saint Louis | Missouri | United States | 63110 |
| 27 | Research Site | Saint Louis | Missouri | United States | 63117 |
| 28 | Research Site | Las Vegas | Nevada | United States | 89106 |
| 29 | Research Site | Las Vegas | Nevada | United States | 89128 |
| 30 | Research Site | Jersey City | New Jersey | United States | 07305 |
| 31 | Research Site | Bronx | New York | United States | 10461 |
| 32 | Research Site | Bronx | New York | United States | 10461 |
| 33 | Research Site | Great Neck | New York | United States | 11021 |
| 34 | Research Site | Manhasset | New York | United States | 11030 |
| 35 | Research Site | New Bern | North Carolina | United States | 28562 |
| 36 | Research Site | Winston-Salem | North Carolina | United States | 27103 |
| 37 | Research Site | Bethlehem | Pennsylvania | United States | 18017 |
| 38 | Research Site | Providence | Rhode Island | United States | 02903 |
| 39 | Research Site | Charleston | South Carolina | United States | 29425 |
| 40 | Research Site | Spartanburg | South Carolina | United States | 29306 |
| 41 | Research Site | Austin | Texas | United States | 78751 |
| 42 | Research Site | El Paso | Texas | United States | 79925 |
| 43 | Research Site | Greenville | Texas | United States | 75402 |
| 44 | Research Site | Houston | Texas | United States | 77054 |
| 45 | Research Site | Houston | Texas | United States | 77074 |
| 46 | Research Site | Houston | Texas | United States | 77090 |
| 47 | Research Site | San Antonio | Texas | United States | 78229 |
| 48 | Research Site | San Antonio | Texas | United States | 78251 |
| 49 | Research Site | San Antonio | Texas | United States | 78258 |
| 50 | Research Site | Shenandoah | Texas | United States | 77384 |
| 51 | Research Site | Saint George | Utah | United States | 84770 |
| 52 | Research Site | Newport News | Virginia | United States | 23606 |
| 53 | Research Site | Norfolk | Virginia | United States | 23502 |
| 54 | Research Site | Milwaukee | Wisconsin | United States | 53226 |
| 55 | Research Site | Corrientes | Argentina | W3400AMZ | |
| 56 | Research Site | Córdoba | Argentina | X5016LIG | |
| 57 | Research Site | Junín | Argentina | 6000 | |
| 58 | Research Site | Mar del Plata | Argentina | B7600DBZ | |
| 59 | Research Site | Pergamino | Argentina | B2700LDK | |
| 60 | Research Site | San Luis | Argentina | 5700 | |
| 61 | Research Site | San Luis | Argentina | D5700CTA | |
| 62 | Research Site | Santa Rosa | Argentina | L6300 | |
| 63 | Research Site | Sarandi | Argentina | B1872EEC | |
| 64 | Research Site | Graz | Austria | 8036 | |
| 65 | Research Site | Innsbruck | Austria | 6020 | |
| 66 | Research Site | Wien | Austria | 1090 | |
| 67 | Research Site | Belo Horizonte | Brazil | 30150-221 | |
| 68 | Research Site | Brasilia | Brazil | 70390-700 | |
| 69 | Research Site | Curitiba | Brazil | 80230-130 | |
| 70 | Research Site | Curitiba | Brazil | 80440-020 | |
| 71 | Research Site | Joinville | Brazil | 89227-680 | |
| 72 | Research Site | Maringá | Brazil | 87060-040 | |
| 73 | Research Site | Porto Alegre | Brazil | 90020-090 | |
| 74 | Research Site | Porto Alegre | Brazil | 90160-093 | |
| 75 | Research Site | Recife | Brazil | 50720-635 | |
| 76 | Research Site | Ribeirao Preto | Brazil | 14025-170 | |
| 77 | Research Site | Rio De Janeiro | Brazil | 20551-030 | |
| 78 | Research Site | Sao Paulo | Brazil | 04039-000 | |
| 79 | Research Site | Sao Paulo | Brazil | 05403-9000 | |
| 80 | Research Site | São Paulo | Brazil | 05024-040 | |
| 81 | Research Site | Blagoevgrad | Bulgaria | 2700 | |
| 82 | Research Site | Dupnitsa | Bulgaria | 2600 | |
| 83 | Research Site | Gotse Delchev | Bulgaria | 2900 | |
| 84 | Research Site | Haskovo | Bulgaria | 6300 | |
| 85 | Research Site | Razlog | Bulgaria | 2760 | |
| 86 | Research Site | Samokov | Bulgaria | 2000 | |
| 87 | Research Site | Sandanski | Bulgaria | 2800 | |
| 88 | Research Site | Silistra | Bulgaria | 7500 | |
| 89 | Research Site | Smolyan | Bulgaria | 3700 | |
| 90 | Research Site | Sofia | Bulgaria | 1407 | |
| 91 | Research Site | Sofia | Bulgaria | 1606 | |
| 92 | Research Site | Varna | Bulgaria | 9010 | |
| 93 | Research Site | Yambol | Bulgaria | 8600 | |
| 94 | Research Site | Fredericton | New Brunswick | Canada | E3B 5N5 |
| 95 | Research Site | Saint John | New Brunswick | Canada | E2L 4L2 |
| 96 | Research Site | Halifax | Nova Scotia | Canada | B3H 2Y9 |
| 97 | Research Site | Sydney | Nova Scotia | Canada | B1P 1P3 |
| 98 | Research Site | Oshawa | Ontario | Canada | L1G 2B9 |
| 99 | Research Site | Toronto | Ontario | Canada | M3M 0B2 |
| 100 | Research Site | Toronto | Ontario | Canada | M5C 2T2 |
| 101 | Research Site | Greenfield Park | Quebec | Canada | J4V 2H1 |
| 102 | Research Site | Montreal | Quebec | Canada | H1T 2M4 |
| 103 | Research Site | Montreal | Quebec | Canada | H2T 3B3 |
| 104 | Research Site | Montreal | Quebec | Canada | H3T 1E4 |
| 105 | Research Site | Montreal | Quebec | Canada | H4J 1C5 |
| 106 | Research Site | Quebec | Canada | G1R 2J6 | |
| 107 | Research Site | Beijing | China | 100029 | |
| 108 | Research Site | Beijing | China | 100034 | |
| 109 | Research Site | Beijing | China | ||
| 110 | Research Site | Changchun | China | 130021 | |
| 111 | Research Site | Changsha | China | 410004 | |
| 112 | Research Site | Changsha | China | 410008 | |
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| 116 | Research Site | Chengdu | China | 610000 | |
| 117 | Research Site | Dongguan | China | 523009 | |
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| 119 | Research Site | Fuzhou | China | 350001 | |
| 120 | Research Site | Guangzhou | China | 510080 | |
| 121 | Research Site | Guangzhou | China | 510630 | |
| 122 | Research Site | Guilin | China | 541000 | |
| 123 | Research Site | Guiyang | China | 550002 | |
| 124 | Research Site | Guiyang | China | 550004 | |
| 125 | Research Site | Haikou | China | 570311 | |
| 126 | Research Site | Hangzhou | China | 310014 | |
| 127 | Research Site | Hefei | China | 230601 | |
| 128 | Research Site | Hengyang | China | 421001 | |
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| 130 | Research Site | Huai'an | China | 223300 | |
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| 133 | Research Site | Lanzhou | China | 730000 | |
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| 135 | Research Site | Nanchang | China | 330006 | |
| 136 | Research Site | Nanjing | China | 210009 | |
| 137 | Research Site | Nanjing | China | 210029 | |
| 138 | Research Site | Ningbo | China | 315010 | |
| 139 | Research Site | Pingxiang | China | 337055 | |
| 140 | Research Site | Qingdao | China | 266011 | |
| 141 | Research Site | Shanghai | China | 200240 | |
| 142 | Research Site | Shanghai | China | 201199 | |
| 143 | Research Site | Shanghai | China | CN-200120 | |
| 144 | Research Site | Shengyang | China | 110004 | |
| 145 | Research Site | Shenzhen | China | 518020 | |
| 146 | Research Site | Taiyuan | China | 030012 | |
| 147 | Research Site | Tianjin | China | 300121 | |
| 148 | Research Site | Tianjin | China | 300192 | |
| 149 | Research Site | Urumqi | China | CN-830004 | |
| 150 | Research Site | Wenzhou | China | 325027 | |
| 151 | Research Site | Wuhan | China | 430010 | |
| 152 | Research Site | WuHan | China | 430022 | |
| 153 | Research Site | Wuhan | China | 430071 | |
| 154 | Research Site | Wuhu | China | 241000 | |
| 155 | Research Site | Wuxi | China | 214023 | |
| 156 | Research Site | Xiamen | China | 361004 | |
| 157 | Research Site | Yinchuan | China | 750004 | |
| 158 | Research Site | Zhengzhou | China | 450052 | |
| 159 | Research Site | Zhuzhou | China | 412007 | |
| 160 | Research Site | Ceske Budejovice | Czechia | 370 01 | |
| 161 | Research Site | Havlickuv Brod | Czechia | 580 22 | |
| 162 | Research Site | Jilemnice | Czechia | 514 01 | |
| 163 | Research Site | Klatovy | Czechia | 339 01 | |
| 164 | Research Site | Liberec | Czechia | 460 63 | |
| 165 | Research Site | Nove Mesto na Morave | Czechia | 692 31 | |
| 166 | Research Site | Praha 4 | Czechia | 140 21 | |
| 167 | Research Site | Tabor | Czechia | 390 03 | |
| 168 | Research Site | Cloppenburg | Germany | 49661 | |
| 169 | Research Site | Düsseldorf | Germany | 40210 | |
| 170 | Research Site | Erlangen | Germany | 91054 | |
| 171 | Research Site | Hannover | Germany | 30625 | |
| 172 | Research Site | Heilbronn | Germany | 74076 | |
| 173 | Research Site | Minden | Germany | 32429 | |
| 174 | Research Site | Potsdam | Germany | 14467 | |
| 175 | Research Site | Stuttgart | Germany | 70376 | |
| 176 | Research Site | Villingen-Schwenningen | Germany | 78052 | |
| 177 | Research Site | Wiesbaden | Germany | 65191 | |
| 178 | Research Site | Baja | Hungary | 6500 | |
| 179 | Research Site | Budapest | Hungary | 1083 | |
| 180 | Research Site | Dunaújváros | Hungary | 2400 | |
| 181 | Research Site | Hatvan | Hungary | 3000 | |
| 182 | Research Site | Kaposvár | Hungary | 7400 | |
| 183 | Research Site | Karcag | Hungary | 5300 | |
| 184 | Research Site | Kistarcsa | Hungary | 2143 | |
| 185 | Research Site | Miskolc | Hungary | 3526 | |
| 186 | Research Site | Nagykanizsa | Hungary | 8800 | |
| 187 | Research Site | Szombathely | Hungary | 9700 | |
| 188 | Research Site | Bassano del Grappa | Italy | 36061 | |
| 189 | Research Site | Bergamo | Italy | 24127 | |
| 190 | Research Site | Bologna | Italy | 40138 | |
| 191 | Research Site | Caserta | Italy | 81100 | |
| 192 | Research Site | Milano | Italy | 20132 | |
| 193 | Research Site | Milano | Italy | 20142 | |
| 194 | Research Site | Monza | Italy | 20052 | |
| 195 | Research Site | Parma | Italy | 43100 | |
| 196 | Research Site | Pavia | Italy | 27100 | |
| 197 | Research Site | Pesaro | Italy | 61121 | |
| 198 | Research Site | Roma | Italy | 00168 | |
| 199 | Research Site | San Giovanni Rotondo | Italy | 71013 | |
| 200 | Research Site | Verona | Italy | 37124 | |
| 201 | Research Site | Fujisawa-shi | Japan | 251-0041 | |
| 202 | Research Site | Fukuoka-shi | Japan | 810-0004 | |
| 203 | Research Site | Hamamatsu-shi | Japan | 434-0018 | |
| 204 | Research Site | Kawasaki-shi | Japan | 210-0852 | |
| 205 | Research Site | Kumagaya-shi | Japan | 360-0831 | |
| 206 | Research Site | Kumamoto-shi | Japan | 861-8520 | |
| 207 | Research Site | Kurashiki-shi | Japan | 710-0051 | |
| 208 | Research Site | Kyoto-shi | Japan | 600-8216 | |
| 209 | Research Site | Moriya-shi | Japan | 3020118 | |
| 210 | Research Site | Nagano-shi | Japan | 380-0904 | |
| 211 | Research Site | Nagasaki-shi | Japan | 852-8053 | |
| 212 | Research Site | Nakagami-gun | Japan | 901-2393 | |
| 213 | Research Site | Nakano-shi | Japan | 383-8505 | |
| 214 | Research Site | Okinawa-shi | Japan | 904-2143 | |
| 215 | Research Site | Omihachiman-shi | Japan | 523-0082 | |
| 216 | Research Site | Sashima-gun | Japan | 306-0433 | |
| 217 | Research Site | Setagaya-ku | Japan | 158-0094 | |
| 218 | Research Site | Shiroishi-shi | Japan | 989-0231 | |
| 219 | Research Site | Tamana-shi | Japan | 865-0016 | |
| 220 | Research Site | Toride-shi | Japan | 302-0011 | |
| 221 | Research Site | Tsuchiura-shi | Japan | 300-0062 | |
| 222 | Research Site | Tsuchiura-shi | Japan | 300-0835 | |
| 223 | Research Site | Tsukuba-shi | Japan | 305-0861 | |
| 224 | Research Site | Ushiku-shi | Japan | 300-1296 | |
| 225 | Research Site | Yatomi-shi | Japan | 498-0006 | |
| 226 | Research Site | Culiacán | Mexico | 80230 | |
| 227 | Research Site | D.F | Mexico | 14000 | |
| 228 | Research Site | Mazatlán | Mexico | 82000 | |
| 229 | Research Site | Mexico | Mexico | 01710 | |
| 230 | Research Site | Morelia | Mexico | 58260 | |
| 231 | Research Site | Veracruz | Mexico | 91910 | |
| 232 | Research Site | Xalapa | Mexico | 91020 | |
| 233 | Research Site | Zapopan | Mexico | 45138 | |
| 234 | Research Site | Bellavista | Peru | CALLAO 2 | |
| 235 | Research Site | Cusco | Peru | CUSCO 01 | |
| 236 | Research Site | Lima | Peru | 14 | |
| 237 | Research Site | Lima | Peru | 15036 | |
| 238 | Research Site | Lima | Peru | 15046 | |
| 239 | Research Site | Lima | Peru | 15088 | |
| 240 | Research Site | Lima | Peru | LIMA 01 | |
| 241 | Research Site | Piura | Peru | 20001 | |
| 242 | Research Site | Gdańsk | Poland | 80-462 | |
| 243 | Research Site | Kielce | Poland | 25-736 | |
| 244 | Research Site | Leżajsk | Poland | 37-300 | |
| 245 | Research Site | Oleśnica | Poland | 56-400 | |
| 246 | Research Site | Olkusz | Poland | 32-300 | |
| 247 | Research Site | Pszczyna | Poland | 43-200 | |
| 248 | Research Site | Tczew | Poland | 83-110 | |
| 249 | Research Site | Wołomin | Poland | 05-200 | |
| 250 | Research Site | Wroclaw | Poland | 50-981 | |
| 251 | Research Site | Łódź | Poland | 90-153 | |
| 252 | Research Site | Łódź | Poland | 92-213 | |
| 253 | Research Site | Żory | Poland | 44-240 | |
| 254 | Research Site | Żyrardów | Poland | 96-300 | |
| 255 | Research Site | Kemerovo | Russian Federation | 650000 | |
| 256 | Research Site | Kemerovo | Russian Federation | 650066 | |
| 257 | Research Site | Kolomna | Russian Federation | 140402 | |
| 258 | Research Site | Moscow | Russian Federation | 129344 | |
| 259 | Research Site | Mytischi | Russian Federation | 141009 | |
| 260 | Research Site | Novosibirsk | Russian Federation | 630087 | |
| 261 | Research Site | Omsk | Russian Federation | 644112 | |
| 262 | Research Site | Penza | Russian Federation | 440034 | |
| 263 | Research Site | Rostov on Don | Russian Federation | 344029 | |
| 264 | Research Site | Saint Petersburg | Russian Federation | 191167 | |
| 265 | Research Site | Saint-Petersburg | Russian Federation | 190103 | |
| 266 | Research Site | Saint-Petersburg | Russian Federation | 197110 | |
| 267 | Research Site | St-Petersburg | Russian Federation | 196247 | |
| 268 | Research Site | Yaroslavl | Russian Federation | 150062 | |
| 269 | Research Site | Banská Bystrica | Slovakia | 975 17 | |
| 270 | Research Site | Bratislava | Slovakia | 85107 | |
| 271 | Research Site | Komárno | Slovakia | 945 75 | |
| 272 | Research Site | Kosice | Slovakia | 04011 | |
| 273 | Research Site | Lucenec | Slovakia | 984 01 | |
| 274 | Research Site | Puchov | Slovakia | 2001 | |
| 275 | Research Site | Spišská Nová Ves | Slovakia | 052 01 | |
| 276 | Research Site | Žilina | Slovakia | 010 01 | |
| 277 | Research Site | Alcala de Henares | Spain | 28805 | |
| 278 | Research Site | Barcelona | Spain | 08025 | |
| 279 | Research Site | Cordoba | Spain | 14004 | |
| 280 | Research Site | Madrid | Spain | 28006 | |
| 281 | Research Site | Madrid | Spain | 28007 | |
| 282 | Research Site | Madrid | Spain | 28031 | |
| 283 | Research Site | Pamplona | Spain | 31008 | |
| 284 | Research Site | Valencia | Spain | 46017 | |
| 285 | Research Site | Kaohsiung | Taiwan | ||
| 286 | Research Site | Keelung | Taiwan | 20448 | |
| 287 | Research Site | Linkou | Taiwan | 244 | |
| 288 | Research Site | New Taipei | Taiwan | 23561 | |
| 289 | Research Site | Taichung | Taiwan | 40705 | |
| 290 | Research Site | Taipei City | Taiwan | 110 | |
| 291 | Research Site | Taipei City | Taiwan | 114 | |
| 292 | Research Site | Taipei | Taiwan | 100 | |
| 293 | Research Site | Taipei | Taiwan | 220216 | |
| 294 | Research Site | Ankara | Turkey | 06800 | |
| 295 | Research Site | Chernivtsі | Ukraine | 58001 | |
| 296 | Research Site | Dnipro | Ukraine | 49005 | |
| 297 | Research Site | Ivano-Frankivsk | Ukraine | 76008 | |
| 298 | Research Site | Ivano-Frankivsk | Ukraine | 78018 | |
| 299 | Research Site | Kherson | Ukraine | 73000 | |
| 300 | Research Site | Kyiv | Ukraine | 01004 | |
| 301 | Research Site | Kyiv | Ukraine | 02125 | |
| 302 | Research Site | Kyiv | Ukraine | 04050 | |
| 303 | Research Site | Kyiv | Ukraine | 04107 | |
| 304 | Research Site | Mykolaiv | Ukraine | 54058 | |
| 305 | Research Site | Odesa | Ukraine | 65074 | |
| 306 | Research Site | Ternopil | Ukraine | 46001 | |
| 307 | Research Site | Uzhhorod | Ukraine | 88018 | |
| 308 | Research Site | Vinnytsia | Ukraine | 21018 | |
| 309 | Research Site | Zaporizhzhia | Ukraine | 69001 | |
| 310 | Research Site | Zaporizhzhia | Ukraine | 69600 | |
| 311 | Research Site | Bristol | United Kingdom | BS105NB | |
| 312 | Research Site | Leicester | United Kingdom | LE5 4PW | |
| 313 | Research Site | Liverpool | United Kingdom | L9 7AL | |
| 314 | Research Site | London | United Kingdom | E1 1BB | |
| 315 | Research Site | London | United Kingdom | SE1 2PR | |
| 316 | Research Site | Preston | United Kingdom | PR2 9HT | |
| 317 | Research Site | Salford | United Kingdom | M6 8HD | |
| 318 | Research Site | Swansea | United Kingdom | SN6 6NL | |
| 319 | Research Site | Wolverhampton | United Kingdom | WV10 OQP | |
| 320 | Research Site | Bien Hoa City | Vietnam | 810000 | |
| 321 | Research Site | Hanoi | Vietnam | 100000 | |
| 322 | Research Site | Hanoi | Vietnam | 10000 | |
| 323 | Research Site | Hanoi | Vietnam | ||
| 324 | Research Site | Ho Chi Minh City | Vietnam | 70000 | |
| 325 | Research Site | Ho Chi Minh | Vietnam | 10000 | |
| 326 | Research Site | Ho Chi Minh | Vietnam | 700000 | |
| 327 | Research Site | Ho Chi Minh | Vietnam | 700000 | |
| 328 | Research Site | Ho Chi Minh | Vietnam | 700000 | |
| 329 | Research Site | Hochiminh | Vietnam | 70000 |
Sponsors and Collaborators
- AstraZeneca
Investigators
- Principal Investigator: Steven Fishbane, Professor, MD, North Shore University Hospital, 300 Community Drive, Manhasset, NY 11030
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT04847232
Other Study ID Numbers:
- D9487C00001
First Posted:
Apr 19, 2021
Last Update Posted:
Jul 21, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by AstraZeneca
Additional relevant MeSH terms: