CKDkb: a knowledge base and platform for drug development against non-alcoholic fatty liver disease

Clinical Trial Details

Trial ID:	L0142
Source ID:	NCT04492722
Associated Drug:	Azd5718
Title:	A Study to Evaluate the Safety and Efficacy of AZD5718 in Participants With Proteinuric Chronic Kidney Disease
Acronym:
Status:	TERMINATED
Study Results:	YES
Results:	https://ClinicalTrials.gov/show/NCT04492722/results
Conditions:	Chronic Kidney Disease
Interventions:	DRUG: AZD5718\|DRUG: Dapagliflozin 10 mg\|DRUG: Placebo
Outcome Measures:	Primary: Change From Baseline in Reduction of Urine Albumin to Creatinine Ratio (ACR) to Week 20, The dose response effect of AZD5718 on urine ACR at 20 weeks was evaluated. Values less than 1 indicate improvement from baseline., Week 1 (Baseline) to Week 20 \| Secondary: Change From Baseline in Reduction of Urine ACR to Week 12, The dose response effect of AZD5718 on urine ACR at 12 weeks was evaluated. Values less than 1 indicate improvement from baseline., Week 1 (Baseline) to Week 12\|Number of Participants With Adverse Events and Serious Adverse Events, The safety and tolerability profile of AZD5718 treatment was assessed, From Screening (Week -4 to 0) to Week 24\|Change From Baseline in 24-hours Mean Systolic Blood Pressure to Week 12, The effect of AZD5718 on ambulatory blood pressure was assessed, Week 1 (Baseline) to Week 12\|Plasma Concentrations of AZD5718, The PK of AZD5718 after repeated oral dosing for 20 weeks was evaluated, From Week 2 to Week 20\|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) to Week 12, The effect of AZD5718 on renal function was evaluated, Week 1 (Baseline), Week 2, Week 4, Week 8, and Week 12
Sponsor/Collaborators:	Sponsor: AstraZeneca \| Collaborators: Parexel\|George Clinical Pty Ltd
Gender:	ALL
Age:	ADULT, OLDER_ADULT
Phases:	PHASE2
Enrollment:	613
Study Type:	INTERVENTIONAL
Study Designs:	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)\|Primary Purpose: TREATMENT
Start Date:	2020-10-01
Completion Date:	2022-09-06
Results First Posted:	2023-12-26
Last Update Posted:	2024-12-20
Locations:	Research Site, Canoga Park, California, 91303, United States\|Research Site, La Mesa, California, 91942, United States\|Research Site, San Carlos, California, 94070, United States\|Research Site, San Francisco, California, 94110, United States\|Research Site, Victorville, California, 92392, United States\|Research Site, Denver, Colorado, 80045, United States\|Research Site, Jacksonville, Florida, 32216, United States\|Research Site, Winter Haven, Florida, 33880, United States\|Research Site, Columbus, Georgia, 31904, United States\|Research Site, Roseville, Michigan, 48066, United States\|Research Site, Hazelwood, Missouri, 63042, United States\|Research Site, Fresh Meadows, New York, 11365, United States\|Research Site, Great Neck, New York, 11021, United States\|Research Site, Jamaica, New York, 11432, United States\|Research Site, Blue Ash, Ohio, 45242, United States\|Research Site, East Providence, Rhode Island, 02914, United States\|Research Site, Memphis, Tennessee, 38104-2127, United States\|Research Site, Austin, Texas, 78738, United States\|Research Site, Houston, Texas, 77099, United States\|Research Site, Pearland, Texas, 77584, United States\|Research Site, San Antonio, Texas, 78215, United States\|Research Site, Schertz, Texas, 78154, United States\|Research Site, Bahia Blanca, B8109, Argentina\|Research Site, Buenos Aires, 1280, Argentina\|Research Site, Cordoba, 5000, Argentina\|Research Site, Cordoba, X5016KEH, Argentina\|Research Site, Cordoba, X5016KET, Argentina\|Research Site, Junín, 6000, Argentina\|Research Site, Mar del Plata, B7600, Argentina\|Research Site, Belem, 66073-005, Brazil\|Research Site, Brasilia, 71625-175, Brazil\|Research Site, Curitiba, 80215-901, Brazil\|Research Site, Fortaleza, 60430-375, Brazil\|Research Site, Meireles, 60160-230, Brazil\|Research Site, Porto Alegre, 90035-074, Brazil\|Research Site, Porto Alegre, 90430-001, Brazil\|Research Site, Santo Andre, 09090-790, Brazil\|Research Site, Sao Paulo, 05403-9000, Brazil\|Research Site, São Paulo, 01323-020, Brazil\|Research Site, São Paulo, 05016-090, Brazil\|Research Site, Aschaffenburg, 63739, Germany\|Research Site, Berlin, 13509, Germany\|Research Site, Essen, 45136, Germany\|Research Site, Trier, 54292, Germany\|Research Site, Balatonfüred, 8230, Hungary\|Research Site, Budapest, 1083, Hungary\|Research Site, Budapest, 1115, Hungary\|Research Site, Debrecen, 4032, Hungary\|Research Site, Szentes, 6600, Hungary\|Research Site, Szigetvár, 7900, Hungary\|Research Site, Afula, 1834111, Israel\|Research Site, Ashdod, 7747629, Israel\|Research Site, Ashkelon, 78306, Israel\|Research Site, Haifa, 34362, Israel\|Research Site, Jerusalem, 91031, Israel\|Research Site, Ageo, 362-8588, Japan\|Research Site, Asahikawa-shi, 070-8530, Japan\|Research Site, Chiba-shi, 261-0004, Japan\|Research Site, Hiroshima, 732-0057, Japan\|Research Site, Kasugai-shi, 486-8510, Japan\|Research Site, Kitakyushu, 805-8508, Japan\|Research Site, Koga-shi, 306-0041, Japan\|Research Site, Kyoto-shi, 604-8845, Japan\|Research Site, Mito-shi, 311-4198, Japan\|Research Site, Morioka-shi, 020-0066, Japan\|Research Site, Osaka-shi, 530-0005, Japan\|Research Site, Osaka-shi, 558-8558, Japan\|Research Site, Osaka, 553-0003, Japan\|Research Site, Sashima-gun, 306-0433, Japan\|Research Site, Shizuoka-shi, 420-8630, Japan\|Research Site, Toride-shi, 302-0022, Japan\|Research Site, Yokohama-shi, 234-0054, Japan\|Research Site, Yokohama-shi, 236-0004, Japan\|Research Site, Yokohama-shi, 247-8581, Japan\|Research Site, Kota Kinabalu, 88586, Malaysia\|Research Site, Kuala Lumpur, 50586, Malaysia\|Research Site, Kuala Lumpur, 56000, Malaysia\|Research Site, Kuala Lumpur, 59100, Malaysia\|Research Site, Malacca, 78300, Malaysia\|Research Site, Seremban, 70300, Malaysia\|Research Site, Seri Manjung, 32040, Malaysia\|Research Site, Sibu, 96000, Malaysia\|Research Site, Bialystok, 15-375, Poland\|Research Site, Białystok, 15-435, Poland\|Research Site, Kraków, 31-559, Poland\|Research Site, Oswiecim, 32-600, Poland\|Research Site, Rzeszow, 35-055, Poland\|Research Site, Łódź, 92-213, Poland\|Research Site, Kaohsiung City, 82445, Taiwan\|Research Site, Kaohsiung, 833, Taiwan\|Research Site, Keelung, 20448, Taiwan\|Research Site, New Taipei City, 23148, Taiwan\|Research Site, Taichung, 40443, Taiwan\|Research Site, Taichung, 40705, Taiwan\|Research Site, Taichung, 433, Taiwan\|Research Site, Taipei 112, Taiwan\|Research Site, Taipei, 100, Taiwan\|Research Site, Taipei, 116, Taiwan\|Research Site, Dnipro, 49005, Ukraine\|Research Site, Dnipro, 49038, Ukraine\|Research Site, Ivano-Frankivsk, 76000, Ukraine\|Research Site, Ivano-Frankivsk, 76014, Ukraine\|Research Site, Kyiv, 02125, Ukraine\|Research Site, Kyiv, 03049, Ukraine\|Research Site, Kyiv, 1004, Ukraine\|Research Site, Lviv, 79010, Ukraine\|Research Site, Uzhhorod, 88018, Ukraine\|Research Site, Vinnytsia, 21001, Ukraine\|Research Site, Vinnytsia, 21010, Ukraine\|Research Site, Zaporizhzhia, 69600, Ukraine\|Research Site, Zhytomyr, 10002, Ukraine
URL:	https://clinicaltrials.gov/show/NCT04492722

Knowledge Graph
Associated Data

Drug ID	Drug Name	Type	DrugBank ID	Targets	Category	Latest Progress
D445	Dapagliflozin	small molecule	DB06292				Details

Clinical Trial Details

Summary

Knowledge Graph

Associated Data

Associated NAFLD Drugs (1)