A Study to Investigate Outcomes With Elecoglipron Compared With Placebo in Adult Participants With Chronic Kidney Disease. (Elevate-CKD)
August 4, 2026 updated by: AstraZeneca
A Phase III, Randomized, Double-blind, Parallel-group, Placebo-controlled Multicenter Study to Evaluate the Effect of Elecoglipron in Reducing Renal Outcomes and Mortality in Participants With Chronic Kidney Disease (Elevate-CKD)
This is a Phase III, randomized, double-blind, parallel-group, placebo-controlled multicenter study to investigate outcomes with elecoglipron compared with placebo in participants with CKD with and without T2DM who are on background SGLT2i (dapagliflozin) as GDMT and other SoC treatments for CKD.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
7000
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: AstraZeneca Clinical Study Information Center
- Phone Number: 1-877-240-9479
- Email: information.center@astrazeneca.com
Study Locations
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Buenos Aires, Argentina, C1060AAB
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Buenos Aires, Argentina, C1056
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CABA, Argentina, C1425HFA
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Caba, Argentina, C1128AAF
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Ciudad de Buenos Aires, Argentina, C1094AAD
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Ciudad de Buenos Aires, Argentina, 1128
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Córdoba, Argentina, X5006CBI
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La Plata, Argentina, B1900
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Mar del Plata, Argentina, 7600
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Mar del Plata, Argentina, B7600
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Rosario, Argentina, 2000
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Rosario, Argentina, S2000CVD
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San Nicolás, Argentina, B2900DMH
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Santa Rosa, Argentina, 6300
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Castle Hill, Australia, 2154
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Fitzroy, Australia, 3065
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Gosford, Australia, 2250
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Perth, Australia, 6000
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Southport, Australia, 4215
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Wollongong, Australia, 2500
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Barretos, Brazil, 14784-400
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Belo Horizonte, Brazil, 30150-320
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Belém, Brazil, 66073-005
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Bragança Paulista, Brazil, 12916-542
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Brasília, Brazil, 71625-009
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Campina Grande do Sul, Brazil, 83.430-000
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Campinas, Brazil, 13060-080
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Campinas, Brazil, 13092133
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Curitiba, Brazil, 80810-040
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Joinville, Brazil, 89227-680
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Natal, Brazil, 59020-035
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Porto Alegre, Brazil, 90020-090
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Porto Alegre, Brazil, 9061-000
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Porto Alegre, Brazil, 90630-165
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Presidente Prudente, Brazil, 19050-680
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São José dos Campos, Brazil, 12230-001
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São Paulo, Brazil, 01228-000
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São Paulo, Brazil, 04038-031
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São Paulo, Brazil, 01327-001
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São Paulo, Brazil, 05403-9000
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Plovdiv, Bulgaria, 4000
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Alberta
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Calgary, Alberta, Canada, T3R 1W9
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Edmonton, Alberta, Canada, T6G 2G3
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British Columbia
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Vancouver, British Columbia, Canada, V5Y 3W2
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Manitoba
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Winnipeg, Manitoba, Canada, R2V 3M3
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Ontario
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Toronto, Ontario, Canada, M4G 3E8
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Waterloo, Ontario, Canada, N2T 0C1
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Quebec
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Montreal, Quebec, Canada, H4J 1C5
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Araucania, Chile, 4781151
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Osorno, Chile, 5311092
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Region Metropolitana, Chile, 7550000
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Santiago, Chile, 8330034
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Santiago, Chile, 7510187
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Temuco, Chile, 4810345
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Victoria, Chile, 4720000
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Viña del Mar, Chile, 2540488
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Hradec Králové, Czechia, 50005
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Humpolec, Czechia, 396 01
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Jilemnice, Czechia, 514 01
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Liberec, Czechia, 46014
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Mariánské Lázně, Czechia, 35301
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Nové Město na Moravě, Czechia, 692 31
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Nový Jičín, Czechia, 741 01
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Náchod, Czechia, 547 01
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Ostrava, Czechia, 70030
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Prague, Czechia, 100 34
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Prague, Czechia, 160 00
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Prague, Czechia, 130 00
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Tábor, Czechia, 390 03
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Třebíč, Czechia, 674 01
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Aalborg, Denmark, 9000
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Aarhus, Denmark, 8200
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Copenhagen E, Denmark, 2100
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Herlev, Denmark, 2730
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Herning, Denmark, 7400
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Holbæk, Denmark, 4300
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Roskilde, Denmark, 4000
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Helsinki, Finland, 00290
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Jyväskylä, Finland, 40620
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Oulu, Finland, 90220
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Tampere, Finland, 33100
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Tampere, Finland, 33101
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Turku, Finland, 20100
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Ahrensburg, Germany, 22926
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Bad Mergentheim, Germany, 97980
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Bad Nenndorf, Germany, 31542
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Berlin, Germany, 10249
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Berlin, Germany, 10117
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Berlin, Germany, 10787
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Berlin, Germany, 12203
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Bonn, Germany, 53127
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Brandenburg an der Havel, Germany, 14770
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Braunschweig, Germany, 38126
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Chemnitz, Germany, 09116
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Cloppenburg, Germany, 49661
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Cuxhaven, Germany, 27472
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Dortmund, Germany, 44137
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Dresden, Germany, 1307
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Duisburg, Germany, 47269
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Erlangen, Germany, 91054
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Essen, Germany, 45122
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Frankfurt, Germany, 60596
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Frankfurt am Main, Germany, 60431
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Freiburg im Breisgau, Germany, 79110
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Fulda, Germany, 36037
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Gladbeck, Germany, 45968
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Goslar, Germany, 38642
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Göttingen, Germany, 37075
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Hamburg, Germany, 21109
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Hamburg, Germany, 22041
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Hamburg, Germany, 22143
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Hanover, Germany, 30625
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Hanover, Germany, 30159
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Herne, Germany, 44625
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Jerichow, Germany, 39319
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Kiel, Germany, 24105
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Landshut, Germany, 84034
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Leipzig, Germany, 04179
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Leipzig, Germany, 04177
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Lübeck, Germany, 23552
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Magdeburg, Germany, 39120
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Mainz, Germany, 55131
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Mannheim, Germany, 68167
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Nuremberg, Germany, 90443
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Nuremberg, Germany, 90471
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Reinfeld (Holstein), Germany, 23858
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Riesa, Germany, 01589
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Rostock, Germany, 18057
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Stuttgart, Germany, 70376
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Ulm, Germany, 89081
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Wiesbaden, Germany, 65189
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Würzburg, Germany, 97080
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Alexandroupoli, Greece, 68100
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Athens, Greece, 11527
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Athens, Greece, 12462
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Athens, Greece, 15125
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Chios, Greece, 82100
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Heraklion, Greece, 71500
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Ioannina, Greece, 45500
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Larissa, Greece, 41500
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Pátrai, Greece, 26504
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Thessaloniki, Greece, 54645
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Thessaloniki, Greece, 54642
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Thessaloniki, Greece, 57001
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Szeged, Hungary, 6725
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Chennai, India, 600037
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Ashkelon, Israel, 78278
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Be’er Ya‘aqov, Israel, 70300
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Hadera, Israel, 38100
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Haifa, Israel, 34362
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Holon, Israel, 58100
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Kfar Saba, Israel, 4428164
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Nahariya, Israel, 22100
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Ramat Gan, Israel, 52621
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Rehovot, Israel, 76100
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Tiberias, Israel, 15208
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Alessandria, Italy, 15100
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Bari, Italy, 70124
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Bologna, Italy, 40138
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Catania, Italy, 95125
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Chieri, Italy, 10023
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Cinisello Balsamo, Italy, 20092
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Cosenza, Italy, 87100
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Feltre, Italy, 32032
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Foggia, Italy, 71100
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Naples, Italy, 80131
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Pavia, Italy, 27100
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Pordenone, Italy, 33170
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Ranica, Italy, 24020
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Rome, Italy, 00189
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San Fermo della Battaglia, Italy, 22020
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San Giovanni Rotondo, Italy, 71013
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Trieste, Italy, 34149
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Aira, Japan, 899-5421
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Akita, Japan, 010-8543
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Asahikawa-shi, Japan, 070-8530
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Chūōku, Japan, 103-0002
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Fujisawa-shi, Japan, 251-0041
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Fukuoka, Japan, 814-0180
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Hachioji-shi, Japan, 192-0083
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Hamamatsu, Japan, 431-3192
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Hiroshima, Japan, 734-8551
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Ichikawa-shi, Japan, 272-8516
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Ina-shi, Japan, 396-8555
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Iruma-Gun, Japan, 350-0495
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Izunokuni-shi, Japan, 410-2295
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Kamakura-shi, Japan, 247-0056
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Kanazawa, Japan, 920-8650
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Kasuga-shi, Japan, 816-0864
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Kasugai-shi, Japan, 486-8510
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Kawachinagano-shi, Japan, 586-8521
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Kitakyushu, Japan, 802-8555
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Kitakyushu-shi, Japan, 802-0077
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Kumamoto, Japan, 862-0950
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Kurume, Japan, 830-8543
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Kuwana-shi, Japan, 511-0061
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Matsumoto-shi, Japan, 390-1401
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Minatoku, Japan, 108-0073
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Minokamo Shi, Japan, 505-8510
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Moriyama-shi, Japan, 524-8524
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Nagoya, Japan, 451-8511
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Nagoya, Japan, 468-0009
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Naka, Japan, 311-0113
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Naka, Japan, 311-0133
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Okayama, Japan, 700-0804
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Okayama, Japan, 700-8557
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Osaka, Japan, 559-0012
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Osaka, Japan, 558-8558
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Oyama-shi, Japan, 323-0022
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Sakaishi, Japan, 593-8304
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Sakushu, Japan, 385-8558
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Sapporo, Japan, 062-0931
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Sapporo, Japan, 060-0062
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Sasebo-shi, Japan, 857-8511
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Shinjuku-ku, Japan, 160-0023
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Suita-shi, Japan, 565-0871
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Suwa-shi, Japan, 392-8510
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Takasago-shi, Japan, 676-0812
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Tsu, Japan, 514-8507
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Ushiku-shi, Japan, 300-1207
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Utsunomiya, Japan, 321-0151
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Yokohama, Japan, 236-0004
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Yokohama, Japan, 234-0054
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Yokohama, Japan, 230-8765
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Ōita, Japan, 870-0039
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Ipoh, Malaysia, 30990
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Bergen, Norway, 5021
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Bodø, Norway, 8005
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Drammen, Norway, 3004
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Grålum, Norway, 1714
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Haugesund, Norway, 5528
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Levanger, Norway, 7601
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Lørenskog, Norway, 1478
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Oslo, Norway, 0450
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Oslo, Norway, 0586
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Oslo, Norway, 0456
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Oslo, Norway, 0369
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Skedsmokorset, Norway, N-2020
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Skien, Norway, 3710
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Stavanger, Norway, N-4011
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Tromsø, Norway, N-9038
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Trondheim, Norway, 7006
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Tønsberg, Norway, 3116
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Chorrillos, Peru, Lima 9
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Lima, Peru, LIMA 27
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Lima, Peru, 14
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Lima, Peru, LIMA 01
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Lima, Peru, 15088
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Lima, Peru, 15082
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Davao City, Philippines, 8000
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Davao City, Philippines, PH-8000
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Iloilo City, Philippines, 5000
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Las Piñas, Philippines, 1742
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Manadaluyong City, Philippines, 1552
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Pasig, Philippines, 1605
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Quezon City, Philippines, 1101
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Quezon City, Philippines, 1112
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Quezon City, Philippines, 0870
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Bialystok, Poland, 15-481
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Będzin, Poland, 42-500
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Czeladź, Poland, 41-250
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Gmina Świecie, Poland, 86-100
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Katowice, Poland, 40-648
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Kwidzyn, Poland, 82-500
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Lodz, Poland, 92-213
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Lublin, Poland, 20-011
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Olsztyn, Poland, 10-561
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Olsztyn, Poland, 10-117
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Poznan, Poland, 60-355
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Poznan, Poland, 61-251
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Rzeszów, Poland, 35-205
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Tczew, Poland, 83-110
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Warsaw, Poland, 04-141
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Warsaw, Poland, 00-719
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Włocławek, Poland, 87-800
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Żywiec, Poland, 34-300
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Bucharest, Romania, 22328
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Bucharest, Romania, 010507
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Bucharest, Romania, 011053
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Bucharest, Romania, 031141
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Bucharest, Romania, 060044
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Cluj-Napoca, Romania, 400349
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Iași, Romania, 700515
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Oradea, Romania, 410032
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Oradea, Romania, 410469
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Oradea, Romania, 410001
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Oradea, Romania, 410562
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Ploieşti, Romania, 100179
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Timișoara, Romania, 300723
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Timișoara, Romania, 300736
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Belgrade, Serbia, 11000
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Belgrade, Serbia, 11070
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Belgrade, Serbia, 11080
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Kragujevac, Serbia, 34000
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Kruševac, Serbia, 37000
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Niš, Serbia, 18000
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Pančevo, Serbia, 26101
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Anyang-si, South Korea, 14068
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Busan, South Korea, 49241
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Cheonan-si, South Korea, 31151
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Daejeon, South Korea, 34943
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Goyang-si, South Korea, 10380
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Guri-si, South Korea, 11923
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Seoul, South Korea, 03080
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Seoul, South Korea, 03722
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Seoul, South Korea, 06591
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Badajoz, Spain, 06080
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Barcelona, Spain, 08035
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Barcelona, Spain, 08036
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Burgos, Spain, 09006
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Córdoba, Spain, 14004
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Granada, Spain, 18014
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Madrid, Spain, 28041
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Majadahonda, Spain, 28222
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Málaga, Spain, 29010
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Pamplona, Spain, 31008
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Valencia, Spain, 46010
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Valencia, Spain, 46026
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Falun, Sweden, 79182
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Gothenburg, Sweden, 41345
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Karlstad, Sweden, 651 85
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Linköping, Sweden, 581 85
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Lund, Sweden, 221 85
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Stockholm, Sweden, 141 86
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Stockholm, Sweden, SE-18288
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Uppsala, Sweden, 75185
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Vaxjo, Sweden, 352 34
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Örebro, Sweden, 70185
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Changhua, Taiwan, 500
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Kaohsiung City, Taiwan, 833
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New Taipei City, Taiwan, 220
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Taichung, Taiwan, 40705
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Taichung, Taiwan, 40447
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Taichung, Taiwan, 402
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Taichung, Taiwan, 433004
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Tainan, Taiwan, 704
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Taipei, Taiwan, 10002
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Taipei, Taiwan, 110
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Taipei, Taiwan, 11696
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Taoyuan, Taiwan, 333
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Yung Kang City, Taiwan, 71044
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Bangkok, Thailand, 10210
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Bangkok, Thailand, 10300
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Bangkok, Thailand, 10330
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Bangkok, Thailand, 10400
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Bangkok, Thailand, 10700
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Bangkok, Thailand, 10220
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Banphaeo, Thailand, 74120
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Hat Yai, Thailand, 90110
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Khlong Luang, Thailand, 12120
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Muang, Thailand, 50200
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Phitsanulok, Thailand, 65000
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Phutthamonthon, Thailand, 73170
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Ratchaburi, Thailand, 70000
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Ubonratchathani, Thailand, 34000
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Ivano-Frankivsk, Ukraine, 76018
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Kyiv, Ukraine, 01601
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Kyiv, Ukraine, 04114
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Kyiv, Ukraine, 02002
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Kyiv, Ukraine, 03037
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Kyiv, Ukraine, 03049
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Kyiv, Ukraine, 03057
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Kyiv, Ukraine, 04210
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Lviv, Ukraine, 79016
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Vinnytsia, Ukraine, 21029
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Vinnytsia, Ukraine, 21001
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Aberdeen, United Kingdom, AB25 2ZN
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Cardiff, United Kingdom, CF14 4XW
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Corby, United Kingdom, NN18 9EZ
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Coventry, United Kingdom, CV3 4FJ
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Dundee, United Kingdom, DD1 9SY
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Glasgow, United Kingdom, G51 4TF
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Liverpool, United Kingdom, L9 7AL
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London, United Kingdom, SE5 9RS
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London, United Kingdom, EC1M 6BQ
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Metropolitan Borough of Wirral, United Kingdom, CH48 5AA
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Northwood, United Kingdom, HA6 2RN
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Nottingham, United Kingdom, NG7 2QW
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Portsmouth, United Kingdom, PO6 3LY
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Shipley, United Kingdom, BD18 3SA
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Swansea, United Kingdom, SN6 6NL
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Thetford, United Kingdom, IP24 1JD
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York, United Kingdom, YO21 8HE
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Alabama
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Sheffield, Alabama, United States, 35660
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Arizona
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Surprise, Arizona, United States, 85374
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California
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Chula Vista, California, United States, 91910
- Research Site
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Connecticut
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Waterbury, Connecticut, United States, 06708
- Research Site
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Illinois
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Chicago, Illinois, United States, 60611
- Research Site
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Kansas
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Topeka, Kansas, United States, 66606
- Research Site
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Maryland
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Beltsville, Maryland, United States, 20705
- Research Site
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Research Site
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Michigan
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Troy, Michigan, United States, 48098
- Research Site
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Minnesota
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Edina, Minnesota, United States, 55435
- Research Site
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Saint Paul, Minnesota, United States, 55117
- Research Site
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New Jersey
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Eatontown, New Jersey, United States, 07724
- Research Site
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New York
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Albany, New York, United States, 12205
- Research Site
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Buffalo, New York, United States, 14215
- Research Site
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Mineola, New York, United States, 11501
- Research Site
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North Carolina
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Morehead City, North Carolina, United States, 28557
- Research Site
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Shelby, North Carolina, United States, 28150
- Research Site
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Statesville, North Carolina, United States, 28625
- Research Site
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Wilmington, North Carolina, United States, 28401
- Research Site
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Wilmington, North Carolina, United States, 28403
- Research Site
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Ohio
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Maumee, Ohio, United States, 43537
- Research Site
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South Dakota
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Rapid City, South Dakota, United States, 57701
- Research Site
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Tennessee
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Knoxville, Tennessee, United States, 37912
- Research Site
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Morristown, Tennessee, United States, 37813
- Research Site
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Texas
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Arlington, Texas, United States, 76015
- Research Site
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Dallas, Texas, United States, 75246
- Research Site
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Houston, Texas, United States, 77054
- Research Site
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Lubbock, Texas, United States, 79430
- Research Site
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Mesquite, Texas, United States, 75149
- Research Site
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San Antonio, Texas, United States, 78230
- Research Site
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Shenandoah, Texas, United States, 77384
- Research Site
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Utah
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South Salt Lake, Utah, United States, 84115
- Research Site
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Virginia
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Norfolk, Virginia, United States, 23502
- Research Site
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Da Nang, Vietnam, 55000
- Research Site
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Haiphong, Vietnam, 180000
- Research Site
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Hanoi, Vietnam, 100000
- Research Site
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Hanoi, Vietnam, 10000
- Research Site
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Ho Chi Minh City, Vietnam, 700000
- Research Site
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Ho Chi Minh City, Vietnam, 70000
- Research Site
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Ho Chi Minh City, Vietnam, 7000000
- Research Site
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Hochiminh City, Vietnam, 700000
- Research Site
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Hà Nội, Vietnam, 100000
- Research Site
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Hồ Chí Minh, Vietnam, 700000
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Adults with confirmed CKD; UACR ≥30 mg/g and eGFR ≥20 mL/min/1.73 m² within specified ranges.
- On stable, patient maximum tolerated, labeled daily dose of ACEI or ARB for ≥4 weeks at least 28 days before screening.
Exclusion Criteria:
- BMI <23 kg/m² at screening
- History of type 1 diabetes mellitus
- HbA1c ≥10% (86 mmol/mol) at screening
- Currently receiving, or anticipated to receive, therapeutic intervention for diabetic retinopathy and/or macular edema.
- Have had more than one episode of severe hypoglycemia within 180 days prior to screening, or hypoglycemia unawareness
- Acute coronary syndrome, major cardiac procedure, stroke, or TIA within 3 months prior to screening
- Clinically significant condition affecting the upper GI tract or chronic use of any medication that affects gastric motility or gastric emptying
- History of acute or chronic pancreatitis
- History/family history (first degree) of medullary thyroid cancer or MEN2
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Elecoglipron
Elecoglipron tablet once daily
|
Elicoglipron tablet
|
|
Active Comparator: Placebo
Placebo matching Elecoglipron tablet once daily
|
Placebo tablet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To evaluate the effect of elecoglipron compared with placebo in reducing the risk of the composite of ≥ 50% sustained decline in eGFR, ESKD, or all-cause mortality
Time Frame: Event-driven, trial is estimated to be up to 4.5 years
|
Time to the first occurrence of any component of this composite:
Sustained eGFR < 10 mL/min/1.73 m2, or Chronic dialysis treatment, or Receiving a renal transplant - All-cause mortality |
Event-driven, trial is estimated to be up to 4.5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To evaluate the effect of elecoglipron compared with placebo in reducing the risk of the composite of ≥ 50% sustained decline in eGFR, ESKD, or CV and renal death
Time Frame: Event-driven, trial is estimated to be up to 4.5 years
|
Time to the first occurrence of any component of this composite:
Sustained eGFR < 10 mL/min/1.73 m2, or Chronic dialysis treatment, or Receiving a renal transplant - CV and renal death |
Event-driven, trial is estimated to be up to 4.5 years
|
|
To evaluate the effect of elecoglipron compared with placebo in reducing the risk of composite of all-cause mortality, MI, or stroke
Time Frame: Event-driven, trial is estimated to be up to 4.5 years
|
Time to the first occurrence of any component of this composite:
|
Event-driven, trial is estimated to be up to 4.5 years
|
|
To evaluate the effect of elecoglipron compared with placebo in reducing the risk of MACE (CV death, MI, or stroke)
Time Frame: Event-driven, trial is estimated to be up to 4.5 years
|
Time to the first occurrence of any component of this composite:
|
Event-driven, trial is estimated to be up to 4.5 years
|
|
To evaluate the effect of elecoglipron compared with placebo in reducing the risk of all-cause mortality
Time Frame: Event-driven, trial is estimated to be up to 4.5 years
|
Time to death from any cause
|
Event-driven, trial is estimated to be up to 4.5 years
|
|
To evaluate the effect of elecoglipron compared with placebo in reducing the risk of CV death
Time Frame: Event-driven, trial is estimated to be up to 4.5 years
|
Time to death from CV cause
|
Event-driven, trial is estimated to be up to 4.5 years
|
|
To evaluate the effect of elecoglipron compared with placebo in reducing the risk of the pure renal composite of ≥ 50% sustained decline in eGFR, ESKD, or renal death
Time Frame: Event-driven, trial is estimated to be up to 4.5 years
|
Time to the first occurrence of any component of this composite:
Sustained eGFR < 10 mL/min/1.73 m2, or Chronic dialysis treatment, or Receiving a renal transplant - Renal death |
Event-driven, trial is estimated to be up to 4.5 years
|
|
To evaluate the effect of elecoglipron compared with placebo in reducing the risk of CV death or HF hospitalizations
Time Frame: Event-driven, trial is estimated to be up to 4.5 years
|
Time to the first occurrence of any component of this composite:
|
Event-driven, trial is estimated to be up to 4.5 years
|
|
To evaluate the effect of elecoglipron compared with placebo in reducing the risk of the composite endpoint of CV death, MI, stroke, or HF hospitalizations
Time Frame: Event-driven, trial is estimated to be up to 4.5 years
|
Time to first occurrence of any component of this composite:
|
Event-driven, trial is estimated to be up to 4.5 years
|
|
To evaluate the effect of elecoglipron compared with placebo in reducing the risk of all-cause hospitalization
Time Frame: Event-driven, trial is estimated to be up to 4.5 years
|
Time to hospitalization for any cause
|
Event-driven, trial is estimated to be up to 4.5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
August 28, 2026
Primary Completion (Estimated)
October 4, 2030
Study Completion (Estimated)
October 4, 2030
Study Registration Dates
First Submitted
August 4, 2026
First Submitted That Met QC Criteria
August 4, 2026
First Posted (Actual)
August 10, 2026
Study Record Updates
Last Update Posted (Actual)
August 10, 2026
Last Update Submitted That Met QC Criteria
August 4, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Pathologic Processes
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Chronic Disease
- Disease Attributes
- Renal Insufficiency
- Pathological Conditions, Signs and Symptoms
- Renal Insufficiency, Chronic
Other Study ID Numbers
- D7265C00001
- 2025-523994-41-00 (Ctis)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD Sharing Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles.
For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing Access Criteria
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.
Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.