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

Clinical Trial Details

Trial ID:	L0247
Source ID:	NCT04724837
Associated Drug:	Zibotentan
Title:	Zibotentan and Dapagliflozin for the Treatment of CKD (ZENITH-CKD Trial)
Acronym:	ZENITH-CKD
Status:	COMPLETED
Study Results:	YES
Results:	https://ClinicalTrials.gov/show/NCT04724837/results
Conditions:	Chronic Kidney Disease
Interventions:	DRUG: Zibotentan\|DRUG: Dapagliflozin\|DRUG: Placebo
Outcome Measures:	Primary: Change in Urinary Albumin to Creatinine Ratio (UACR) From Baseline to Week 12, The effect of zibotentan 1.5/dapagliflozin 10 mg versus dapagliflozin 10 mg on UACR was assessed., From baseline (Week 0 [Day 1]) until Week 12 (Day 84) \| Secondary: Change in UACR From Baseline to Week 12, The effect of zibotentan 0.25 mg/dapagliflozin 10 mg versus dapagliflozin 10 mg monotherapy on UACR was assessed., From baseline (Week 0 [Day 1]) until Week 12\|Change in Office Systolic Blood Pressure From Baseline to Week 12, The change in office systolic blood pressure for doses of zibotentan combined with dapagliflozin 10 mg versus dapagliflozin 10 mg monotherapy was assessed., From baseline (Week 0 [Day 1]) until Week 12 (Day 84)\|Change in Office Diastolic Blood Pressure From Baseline to Week 12, The change in office diastolic blood pressure for doses of zibotentan combined with dapagliflozin 10 mg versus dapagliflozin 10 mg monotherapy was assessed., From baseline (Week 0 [Day 1]) until Week 12 (Day 84)\|Change in UACR From Baseline to Week 12, The assessment of dose-response and relationship across different dose of zibotentan/dapagliflozin and dapagliflozin alone on UACR reduction., From baseline (Week 0 [Day 1]) until Week 12 (Day 84)\|Change in eGFR From Baseline to Week 1, Week 12, and Week 14, The effect of different doses of zibotentan and dapagliflozin 10 mg in combination versus dapagliflozin 10 mg monotherapy on eGFR was assessed., From baseline (Week 0 [Day 1]) until Week 1 (Day 8), Week 12 (Day 84), and Week 14 (Day 98)\|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE), The safety and tolerability of all doses of zibotentan combined with dapagliflozin 10 mg and dapagliflozin 10 mg monotherapy was assessed., From Screening (Day -28) until Follow-up visit (Day 98), up to 126 days\|Change in eGFR From Week 1 to Week 12, The effect of different doses of zibotentan and dapagliflozin 10 mg in combination versus dapagliflozin 10 mg monotherapy on eGFR was assessed., From Week 1 (Day 8) to Week 12 (Day 84)
Sponsor/Collaborators:	Sponsor: AstraZeneca
Gender:	ALL
Age:	ADULT, OLDER_ADULT
Phases:	PHASE2
Enrollment:	542
Study Type:	INTERVENTIONAL
Study Designs:	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)\|Primary Purpose: TREATMENT
Start Date:	2021-04-28
Completion Date:	2023-06-01
Results First Posted:	2024-07-30
Last Update Posted:	2024-07-30
Locations:	Research Site, Huntsville, Alabama, 35805, United States\|Research Site, Beverly Hills, California, 90211, United States\|Research Site, Downey, California, 90242, United States\|Research Site, Fountain Valley, California, 92708, United States\|Research Site, Laguna Hills, California, 92653, United States\|Research Site, Los Angeles, California, 90057, United States\|Research Site, Northridge, California, 91324, United States\|Research Site, Ontario, California, 91762, United States\|Research Site, S. Gate, California, 90280, United States\|Research Site, Tarzana, California, 91356, United States\|Research Site, Vacaville, California, 95687, United States\|Research Site, Fort Lauderdale, Florida, 33308, United States\|Research Site, Hialeah, Florida, 33012, United States\|Research Site, New Port Richey, Florida, 34652, United States\|Research Site, Orlando, Florida, 32806, United States\|Research Site, Riverview, Florida, 33578, United States\|Research Site, Tampa, Florida, 33614, United States\|Research Site, Augusta, Georgia, 30904, United States\|Research Site, Fayetteville, Georgia, 30214, United States\|Research Site, Wichita, Kansas, 67214-2943, United States\|Research Site, Owensboro, Kentucky, 42303, United States\|Research Site, Metairie, Louisiana, 70006, United States\|Research Site, Shreveport, Louisiana, 71101, United States\|Research Site, Boston, Massachusetts, 02215, United States\|Research Site, Flint, Michigan, 48504, United States\|Research Site, Flint, Michigan, 48532, United States\|Research Site, Lincoln, Nebraska, 68510, United States\|Research Site, Las Vegas, Nevada, 89128, United States\|Research Site, Greenville, North Carolina, 27834, United States\|Research Site, Jacksonville, North Carolina, 28546, United States\|Research Site, Kinston, North Carolina, 28504, United States\|Research Site, Morehead City, North Carolina, 28557, United States\|Research Site, New Bern, North Carolina, 28562, United States\|Research Site, Wilmington, North Carolina, 28401, United States\|Research Site, Marion, Ohio, 43302, United States\|Research Site, Chester, Pennsylvania, 19013, United States\|Research Site, Memphis, Tennessee, 38104, United States\|Research Site, Memphis, Tennessee, 38119, United States\|Research Site, Arlington, Texas, 76002, United States\|Research Site, Conroe, Texas, 77384, United States\|Research Site, Corpus Christi, Texas, 78414, United States\|Research Site, El Paso, Texas, 79935, United States\|Research Site, Houston, Texas, 77004, United States\|Research Site, Houston, Texas, 77099, United States\|Research Site, Odessa, Texas, 79761, United States\|Research Site, San Antonio, Texas, 78212, United States\|Research Site, Waxahachie, Texas, 75165, United States\|Research Site, Forest, Virginia, 24551, United States\|Research Site, Newport News, Virginia, 23606, United States\|Research Site, Spokane, Washington, 99204, United States\|Research Site, Buenos Aires, C1425AGC, Argentina\|Research Site, Caba, C1120AAC, Argentina\|Research Site, Caba, C1440AAD, Argentina\|Research Site, Cordoba, 5003, Argentina\|Research Site, Corrientes, W3400AMZ, Argentina\|Research Site, Junín, 6000, Argentina\|Research Site, Mar del Plata, B7600FZN, Argentina\|Research Site, Mar del Plata, B7600, Argentina\|Research Site, San Luis, 5700, Argentina\|Research Site, San Miguel de Tucuman, 4000, Argentina\|Research Site, Santa Fe, S3000, Argentina\|Research Site, Adelaide, 5000, Australia\|Research Site, Birtinya, 4575, Australia\|Research Site, Elizabeth Vale, 5112, Australia\|Research Site, Gosford, 2250, Australia\|Research Site, Westmead, 2145, Australia\|Research Site, Botucatu, 18618-687, Brazil\|Research Site, Campinas, 13010-001, Brazil\|Research Site, Curitiba, 80440-020, Brazil\|Research Site, Porto Alegre, 90020-090, Brazil\|Research Site, Santo Andre, 09090-790, Brazil\|Research Site, Sao Paulo, 04039-000, Brazil\|Research Site, Sao Paulo, 5403-000, Brazil\|Research Site, São José do Rio Preto, 15090-000, Brazil\|Research Site, São Paulo, 01228-200, Brazil\|Research Site, Gabrovo, 5300, Bulgaria\|Research Site, Kozloduy, 3320, Bulgaria\|Research Site, Montana, 3400, Bulgaria\|Research Site, Plovdiv, 4023, Bulgaria\|Research Site, Sliven, 8800, Bulgaria\|Research Site, Sofia, 1407, Bulgaria\|Research Site, Sofia, 1510, Bulgaria\|Research Site, Stara Zagora, 6000, Bulgaria\|Research Site, St. John's, Newfoundland and Labrador, A1A 3R5, Canada\|Research Site, London, Ontario, N6A-5A5, Canada\|Research Site, Toronto, Ontario, M5N 1C1, Canada\|Research Site, Waterloo, Ontario, N2T 0C1, Canada\|Research Site, Pula, 52000, Croatia\|Research Site, Vinkovci, 32100, Croatia\|Research Site, Gentofte, 2820, Denmark\|Research Site, Roskilde, 4000, Denmark\|Research Site, Århus N, 8200, Denmark\|Research Site, Batumi, 6010, Georgia\|Research Site, Gori, 1400, Georgia\|Research Site, Gurjaani, 1500, Georgia\|Research Site, Kutaisi, 4600, Georgia\|Research Site, Marneuli, 3000, Georgia\|Research Site, Tbilisi, 0102, Georgia\|Research Site, Tbilisi, 0114, Georgia\|Research Site, Tbilisi, 0144, Georgia\|Research Site, Tbilisi, 0159, Georgia\|Research Site, Tbilisi, 112, Georgia\|Research Site, Debrecen, 4032, Hungary\|Research Site, Hatvan, 3000, Hungary\|Research Site, Miskolc, 3530, Hungary\|Research Site, Bari, 70124, Italy\|Research Site, Genova, 16132, Italy\|Research Site, Germaneto, 88100, Italy\|Research Site, Napoli, 80035, Italy\|Research Site, Napoli, 80131, Italy\|Research Site, Napoli, 80138, Italy\|Research Site, Pavia, 27100, Italy\|Research Site, San Giovanni Rotondo, 71013, Italy\|Research Site, Chiba-shi, 260-8712, Japan\|Research Site, Chuo-ku, 103-0027, Japan\|Research Site, Koshigaya-shi, 343-8577, Japan\|Research Site, Nagoya, 455-8530, Japan\|Research Site, Naka, 311-0113, Japan\|Research Site, Osaka-shi, 530-0001, Japan\|Research Site, Osaka-shi, 558-8558, Japan\|Research Site, Osaka-shi, 559-0012, Japan\|Research Site, Takarazuka-shi, 665-0861, Japan\|Research Site, Tsu-shi, 514-1101, Japan\|Research Site, Ueda-shi, 386-8610, Japan\|Research Site, Yao-shi, 581-0011, Japan\|Research Site, Kuala Lumpur, 59100, Malaysia\|Research Site, Kuantan, 25200, Malaysia\|Research Site, Breda, 4800 RK, Netherlands\|Research Site, Dordrecht, 3300 AK, Netherlands\|Research Site, Bialystok, 15-375, Poland\|Research Site, Krakow, 31-261, Poland\|Research Site, Oświęcim, 32-600, Poland\|Research Site, Poznań, 60-848, Poland\|Research Site, Rzeszow, 35-055, Poland\|Research Site, Rimavska Sobota, 979 01, Slovakia\|Research Site, Bellville, 7530, South Africa\|Research Site, Bloemfontein, 9301, South Africa\|Research Site, Durban, 4001, South Africa\|Research Site, George, 6529, South Africa\|Research Site, Observatory, 7925, South Africa\|Research Site, Pretoria, 0157, South Africa\|Research Site, Pretoria, 0181, South Africa\|Research Site, Somerset West, 7130, South Africa\|Research Site, A Coruna, 15006, Spain\|Research Site, Barcelona, 08035, Spain\|Research Site, Burela, 27880, Spain\|Research Site, Madrid, 28034, Spain\|Research Site, Madrid, 28040, Spain\|Research Site, Majadahonda, 28222, Spain\|Research Site, Malaga, 29010, Spain\|Research Site, Palma de Mallorca, 07010, Spain\|Research Site, Sevilla, 41009, Spain\|Research Site, Valencia, 46010, Spain\|Research Site, Valencia, 46017, Spain\|Research Site, Chernivtsі, 58022, Ukraine\|Research Site, Dnipro, 49102, Ukraine\|Research Site, Kharkiv, 61103, Ukraine\|Research Site, Kyiv, 03049, Ukraine\|Research Site, Kyiv, 1004, Ukraine\|Research Site, Ternopil, 46002, Ukraine\|Research Site, Uzhhorod, 88018, Ukraine\|Research Site, Vinnytsia, 21001, Ukraine\|Research Site, Zaporizhia, 69001, Ukraine\|Research Site, Zhytomyr, 10002, Ukraine
URL:	https://clinicaltrials.gov/show/NCT04724837

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)