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

Clinical Trial Details

Trial ID:	L0584
Source ID:	NCT04595370
Associated Drug:	Azd9977
Title:	Efficacy, Safety and Tolerability of AZD9977 and Dapagliflozin in Participants With Heart Failure and Chronic Kidney Disease
Acronym:	MIRACLE
Status:	COMPLETED
Study Results:	YES
Results:	https://ClinicalTrials.gov/show/NCT04595370/results
Conditions:	Heart Failure\|Chronic Kidney Disease
Interventions:	DRUG: AZD9977\|DRUG: Dapagliflozin
Outcome Measures:	Primary: Percent Change From Baseline in Urinary Albumin to Creatinine Ratio (UACR) at Week 12, The effect of AZD9977 in combination with dapagliflozin compared with dapagliflozin alone on UACR assessed. Urine samples were collected for the analysis of UACR. UACR (milligrams per gram \[mg/g\]) was calculated as 10 x urine albumin (mg per deciliter \[mg/dL\])/urine creatinine (g/dL). Change from baseline in UACR at the end of 12 weeks of study treatment was calculated as the average of the UACR values at Week 12 and was analyzed by a mixed-effects model for repeated measures (MMRM). Due to early removal of arms (AZD9977 150 mg monotherapy and Placebo), the study objectives were revised and the MMRM analysis included the 4 remaining arms (AZD9977 15 mg + Dapagliflozin, AZD9977 50 mg + Dapagliflozin, AZD9977 150 mg + Dapagliflozin, and Dapagliflozin 10 mg). Since 2 arms were removed from the study resulting in fewer participants only descriptive statistics are shown for those two arms without formal comparison., Baseline (Day 1) to Week 12 \| Secondary: Percent Change From Baseline in Urinary Albumin to Creatinine Ratio (UACR) at 12 Weeks to Assess Dose-Response Relationship, The dose-response relationship of dapagliflozin alone and 3 doses of AZD9977 combined with dapagliflozin on UACR was assessed. Urine samples were collected for the analysis of UACR. UACR (mg/g) was calculated as 10 x urine albumin (mg/dL)/urine creatinine (g/dL). Change from baseline in UACR at the end of 12 weeks of study treatment was calculated as the average of the UACR values at Week 12 and was analyzed by a mixed-effects model for repeated measures (MMRM). Due to early removal of arms (AZD9977 150 mg monotherapy and Placebo), the study objectives were revised and the MMRM analysis included the 4 remaining arms (AZD9977 15 mg + Dapagliflozin, AZD9977 50 mg + Dapagliflozin, AZD9977 150 mg + Dapagliflozin, and Dapagliflozin 10 mg). Since 2 arms were removed from the study resulting in fewer participants, only descriptive statistics was shown for those two arms without formal comparison., Baseline (Day 1) to Week 12\|Number of Participants With Adverse Events (AEs), The safety and tolerability of AZD9977 combined with dapagliflozin 10 mg, AZD9977 monotherapy, dapagliflozin 10 mg monotherapy and placebo was assessed., From baseline (Day 1) until Day 113\|Change From Baseline in Serum Potassium (K+), Effect of AZD9977 combined with dapagliflozin 10 mg, AZD9977 monotherapy, dapagliflozin 10 mg monotherapy and placebo on serum K+ was assessed., Baseline (Day 1) and Week 12\|Absolute Value of Serum Potassium Over Time, Effect of AZD9977 combined with dapagliflozin 10 mg, AZD9977 monotherapy, dapagliflozin 10 mg monotherapy and placebo on serum K+ was assessed., Baseline (Day 1) and Week 12\|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR), Effect of AZD9977 combined with dapagliflozin 10 mg, AZD9977 monotherapy, dapagliflozin 10 mg monotherapy and placebo on eGFR was assessed., Baseline (Day 1) and Week 12\|Absolute Value of eGFR Over Time, Effect of all doses of AZD9977 combined with dapagliflozin 10 mg, AZD9977 monotherapy, dapagliflozin 10 mg monotherapy and placebo on eGFR was assessed, Baseline (Day 1) to Week 12
Sponsor/Collaborators:	Sponsor: AstraZeneca
Gender:	ALL
Age:	ADULT, OLDER_ADULT
Phases:	PHASE2
Enrollment:	153
Study Type:	INTERVENTIONAL
Study Designs:	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)\|Primary Purpose: TREATMENT
Start Date:	2021-01-26
Completion Date:	2023-09-22
Results First Posted:	2024-11-19
Last Update Posted:	2024-11-19
Locations:	Research Site, Beverly Hills, California, 90211, United States\|Research Site, Fountain Valley, California, 92708, United States\|Research Site, Northridge, California, 91324, United States\|Research Site, S. Gate, California, 90280, United States\|Research Site, Hialeah, Florida, 33016, United States\|Research Site, Homestead, Florida, 33032, United States\|Research Site, Jacksonville, Florida, 32216, United States\|Research Site, Miami, Florida, 33155, United States\|Research Site, Ocala, Florida, 34474, United States\|Research Site, Tampa, Florida, 33603, United States\|Research Site, Augusta, Georgia, 30904, United States\|Research Site, Columbus, Georgia, 31904, United States\|Research Site, Baltimore, Maryland, 21287, United States\|Research Site, Methuen, Massachusetts, 01844, United States\|Research Site, Saint Louis, Missouri, 63136, United States\|Research Site, Bronx, New York, 10455, United States\|Research Site, New Bern, North Carolina, 28562, United States\|Research Site, Rapid City, South Dakota, 57701, United States\|Research Site, Memphis, Tennessee, 38119, United States\|Research Site, Houston, Texas, 77087, United States\|Research Site, Houston, Texas, 77099, United States\|Research Site, Kingwood, Texas, 77339, United States\|Research Site, McKinney, Texas, 75069, United States\|Research Site, San Antonio, Texas, 78207, United States\|Research Site, Sherman, Texas, 75092, United States\|Research Site, Webster, Texas, 77598, United States\|Research Site, Roeselare, 8800, Belgium\|Research Site, Pleven, 5800, Bulgaria\|Research Site, Plovdiv, 1606, Bulgaria\|Research Site, Plovdiv, 4002, Bulgaria\|Research Site, Plovdiv, 4003, Bulgaria\|Research Site, Sofia, 1233, Bulgaria\|Research Site, Sofia, 1309, Bulgaria\|Research Site, Sofia, 1431, Bulgaria\|Research Site, Sofia, 1510, Bulgaria\|Research Site, Sofia, 1784, Bulgaria\|Research Site, Veliko Turnovo, 5000, Bulgaria\|Research Site, Peterborough, Ontario, K9J 0B2, Canada\|Research Site, Toronto, Ontario, M4N 3M5, Canada\|Research Site, Montreal, Quebec, H2X 0A9, Canada\|Research Site, Quebec, G1R 2J6, Canada\|Research Site, Pardubice, 532 03, Czechia\|Research Site, Praha 2, 120 00, Czechia\|Research Site, Praha 5, 158 00, Czechia\|Research Site, Uherske Hradiste, 68601, Czechia\|Research Site, Aarhus, 8200, Denmark\|Research Site, Herlev, 2730, Denmark\|Research Site, Svendborg, 5700, Denmark\|Research Site, Dresden, 1307, Germany\|Research Site, Frankfurt, 60313, Germany\|Research Site, Jena, 07747, Germany\|Research Site, Leipzig, 04103, Germany\|Research Site, Balatonfüred, 8230, Hungary\|Research Site, Budapest, 1036, Hungary\|Research Site, Budapest, 1122, Hungary\|Research Site, Debrecen, 4032, Hungary\|Research Site, Miskolc, 3530, Hungary\|Research Site, Oroshaza, H-5900, Hungary\|Research Site, Ahmedabad, 382421, India\|Research Site, Chennai, 600081, India\|Research Site, Kolkata, 700020, India\|Research Site, Pune, 411011, India\|Research Site, Roma, 00168, Italy\|Research Site, Chuo-ku, 103-0027, Japan\|Research Site, Hamada-shi, 697-8511, Japan\|Research Site, Hamamatsu-shi, 430-0929, Japan\|Research Site, Hanyu-shi, 348-8505, Japan\|Research Site, Itabashi-ku, 173-8610, Japan\|Research Site, Kasugai-shi, 487-0016, Japan\|Research Site, Kawaguchi, 333-0842, Japan\|Research Site, Kishiwada-shi, 596-8522, Japan\|Research Site, Kobe-shi, 650-0047, Japan\|Research Site, Kobe, 654-0155, Japan\|Research Site, Matsudo-Shi, 271-0077, Japan\|Research Site, Matsumoto-shi, 390-8621, Japan\|Research Site, Ono, 675-1392, Japan\|Research Site, Osaka-shi, 530-0001, Japan\|Research Site, Sapporo-shi, 006-0811, Japan\|Research Site, Sayama, 350-1305, Japan\|Research Site, Takasago-shi, 676-0812, Japan\|Research Site, Takasaki-shi, 370-0829, Japan\|Research Site, Ueda-shi, 386-8610, Japan\|Research Site, Yokohama-shi, 231-8682, Japan\|Research Site, Yokohama-shi, 234-8503, Japan\|Research Site, Yokohama-shi, 236-0004, Japan\|Research Site, Busan, 49201, Korea, Republic of\|Research Site, Gangwon-do, 26426, Korea, Republic of\|Research Site, Seongnam-si, 463-707, Korea, Republic of\|Research Site, Seoul, 03080, Korea, Republic of\|Research Site, Seoul, 06351, Korea, Republic of\|Research Site, Seoul, 06591, Korea, Republic of\|Research Site, Kaunas, 50177, Lithuania\|Research Site, Klaipeda, 92231, Lithuania\|Research Site, Siauliai, LT-76231, Lithuania\|Research Site, Vilnius, 08661, Lithuania\|Research Site, Gdansk, 80-952, Poland\|Research Site, Gdańsk, 80-382, Poland\|Research Site, Katowice, 40-040, Poland\|Research Site, Lublin, 20-709, Poland\|Research Site, Ostrowiec Świętokrzyski, 27-400, Poland\|Research Site, Oława, 55-200, Poland\|Research Site, Oświęcim, 32-600, Poland\|Research Site, Pabianice, 95-200, Poland\|Research Site, Poznań, 60-702, Poland\|Research Site, Skorzewo, 60-185, Poland\|Research Site, Sopot, 81-717, Poland\|Research Site, Szczecin, 71-434, Poland\|Research Site, Toruń, 87-100, Poland\|Research Site, Warszawa, 01-192, Poland\|Research Site, Łódź, 90-127, Poland\|Research Site, Łódź, 92-213, Poland\|Research Site, Łódź, 95-513, Poland\|Research Site, Kazan, Tatarstan, 420012, Russian Federation\|Research Site, Kazan, 420101, Russian Federation\|Research Site, Kemerovo, 650002, Russian Federation\|Research Site, Moscow, 111539, Russian Federation\|Research Site, Moscow, 121552, Russian Federation\|Research Site, Moscow, 125284, Russian Federation\|Research Site, Moscow, 129110, Russian Federation\|Research Site, Saint-Petersburg, 195257, Russian Federation\|Research Site, St Petersburg, 195067, Russian Federation\|Research Site, St. Petersburg, 197022, Russian Federation\|Research Site, St. Petersburg, 197089, Russian Federation\|Research Site, Banska Bystrica, 974 01, Slovakia\|Research Site, Brezno, 977 01, Slovakia\|Research Site, Lucenec, 984 01, Slovakia\|Research Site, Presov, 080 01, Slovakia\|Research Site, Svidnik, 08901, Slovakia\|Research Site, Trencin, 911 01, Slovakia\|Research Site, Barcelona, 08003, Spain\|Research Site, Coruña, 15006, Spain\|Research Site, El Palmar, 30120, Spain\|Research Site, Madrid, 28041, Spain\|Research Site, Málaga, 29010, Spain\|Research Site, Santiago(A Coruña), 15706, Spain\|Research Site, Sevilla, 41009, Spain\|Research Site, Valencia, 46010, Spain\|Research Site, Valencia, 46026, Spain\|Research Site, Goeteborg, 413 46, Sweden\|Research Site, Stockholm, 14186, Sweden\|Research Site, Stockholm, 18288, Sweden\|Research Site, Uppsala, 75185, Sweden\|Research Site, Kaohsiung, 80756, Taiwan\|Research Site, Taichung, 40201, Taiwan\|Research Site, Taipei City, 110, Taiwan\|Research Site, Taipei, 10449, Taiwan\|Research Site, Taipei, 11217, Taiwan\|Research Site, Bangkok, 10400, Thailand\|Research Site, Bangkok, 10700, Thailand\|Research Site, Chaingmai, 50200, Thailand\|Research Site, Khon Kaen, 40002, Thailand\|Research Site, Adana, 01060, Turkey\|Research Site, Kocaeli, 41380, Turkey\|Research Site, Ivano-Frankivsk, 76018, Ukraine\|Research Site, Kharkiv, 61039, Ukraine\|Research Site, Kyiv, 02091, Ukraine
URL:	https://clinicaltrials.gov/show/NCT04595370

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)