Clinical Trial Details
| Trial ID: | L0830 |
| Source ID: | NCT02865850 |
| Associated Drug: | Vadadustat |
| Title: | Efficacy and Safety Study to Evaluate Vadadustat for the Correction or Maintenance Treatment of Anemia in Participants With Incident Dialysis-dependent Chronic Kidney Disease (DD-CKD) |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT02865850/results |
| Conditions: | Anemia|Dialysis-Dependent Chronic Kidney Disease |
| Interventions: | DRUG: Vadadustat|DRUG: Darbepoetin alfa |
| Outcome Measures: | Primary: Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36), The Baseline average was calculated as the average of the Hb values obtained at the screening visit closest to the date of randomization and the randomization visit. The average for the Primary Efficacy Period was calculated as the average Hb value over Weeks 24 to 36. Analysis was conducted using an analysis of covariance (ANCOVA) model with multiple imputation for missing data with Baseline hemoglobin concentration (\<9.5 versus ≥9.5 g/dL), geographic region (United States \[US\] versus European Union \[EU\] versus Rest of World \[ROW\]), and New York Heart Association congestive heart failure (NYHA CHF) class (Class 0 \[no CHF\] or I versus II or III) as covariates., Baseline; Weeks 24 to 36|Median Time to First Major Adverse Cardiovascular Event (MACE), MACE was defined as all-cause mortality, non-fatal myocardial infarction (MI), or non-fatal stroke. The primary safety outcome was positively adjudicated first MACE, which was defined as any death, Endpoint Adjudication Committee (EAC)-confirmed non-fatal MI, or EAC-confirmed non-fatal stroke occurring between the first dose date and each participant's last participation date. INNOVATE MACE results and analysis, by design, was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Results and statistical analysis from study AKB-6548-CI-0016 has been reported in below table and under section "Statistical Analysis 1". Results and statistical analysis of the pooled data from studies AKB-6548-CI-0016 and AKB-6548-CI-0017 has been reported under section "Statistical Analysis 2" of this outcome measure., Up to 176 weeks | Secondary: Change From Baseline in Hb to the Average Over the Secondary Efficacy Period (Weeks 40 to 52), The Baseline average was calculated as the average of the Hb values obtained at the screening visit closest to the date of randomization and the randomization visit. The average for the Secondary Efficacy Period was calculated as the average Hb value over Weeks 40 to 52. Analysis was conducted using an ANCOVA model with multiple imputation for missing data with Baseline hemoglobin concentration (\<9.5 versus ≥9.5 g/dL), geographic region (US versus EU versus ROW), and NYHA CHF class (Class 0 \[no CHF\] or I versus II or III) as covariates., Baseline; Weeks 40 to 52|Median Time to First MACE Plus Hospitalization for Heart Failure or Thromboembolic Event Excluding Vascular Access Thrombosis, MACE was defined as all-cause mortality, non-fatal MI, or non-fatal stroke. Hospitalization for EAC adjudicated heart failure included presentation of participants to an acute care facility requiring an overnight hospitalization (change in calendar day) with an exacerbation of heart failure requiring treatment. EAC confirmed thromboembolic events for this secondary outcome measure included arterial thrombosis, deep vein thrombosis, and pulmonary embolism. INNOVATE MACE results and analysis, by design, was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Results and statistical analysis from study AKB-6548-CI-0016 has been reported in below table and under section "Statistical Analysis 1". Results and statistical analysis of the pooled data from studies AKB-6548-CI-0016 and AKB-6548-CI-0017 has been reported under section "Statistical Analysis 2" of this outcome measure., Up to 176 weeks|Median Time to First Cardiovascular MACE, MACE was defined as all-cause mortality, non-fatal MI, or non-fatal stroke. Cardiovascular MACE analysis differed from the primary MACE endpoint as it included only deaths adjudicated by the EAC as cardiovascular deaths (i.e, only EAC-confirmed cardiovascular deaths) in addition to first events of non-fatal MI or non-fatal stroke. INNOVATE MACE results and analysis, by design, was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Results and statistical analysis from study AKB-6548-CI-0016 has been reported in below table and under section "Statistical Analysis 1". Results and statistical analysis of the pooled data from studies AKB-6548-CI-0016 and AKB-6548-CI-0017 has been reported under section "Statistical Analysis 2" of this outcome measure., Up to 176 weeks|Median Time to First Cardiovascular Death, Cardiovascular death included EAC adjudicated fatal MI, pump failure, sudden death, presumed sudden death, fatal stroke, fatal pulmonary embolism, cardiovascular procedure-related death, other cardiovascular death, and presumed cardiovascular death. INNOVATE MACE results and analysis, by design, was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Results and statistical analysis from study AKB-6548-CI-0016 has been reported in below table and under section "Statistical Analysis 1". Results and statistical analysis of the pooled data from studies AKB-6548-CI-0016 and AKB-6548-CI-0017 has been reported under section "Statistical Analysis 2" of this outcome measure., Up to 176 weeks|Median Time to First All-cause Mortality, Only events that were positively adjudicated and confirmed by the EAC were included in the MACE analyses. INNOVATE MACE results and analysis, by design, was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Results and statistical analysis from study AKB-6548-CI-0016 has been reported in below table and under section "Statistical Analysis 1". Results and statistical analysis of the pooled data from studies AKB-6548-CI-0016 and AKB-6548-CI-0017 has been reported under section "Statistical Analysis 2" of this outcome measure., Up to 176 weeks | Other: Exploratory - Proportion of Participants With Hb Values Within the Target Range During the Primary Evaluation Period (Weeks 24 to 36), Weeks 24 to 36|Exploratory - Proportion of Time With Hb Values Within the Target Range During the Primary Evaluation Period (Weeks 24 to 36), Weeks 24 to 36|Exploratory - Proportion of Time With Hb Values Within the Target Range During the Secondary Evaluation Period (Weeks 40 to 52), Weeks 40 to 52|Exploratory - Proportion of Participants With Hb Values Within the Target Range During the Secondary Evaluation Period (Weeks 40 to 52), Weeks 40 to 52|Exploratory - Proportion of Participants With an Hb Increase of >1.0 g/dL From Baseline Visit, Baseline; up to Week 52|Exploratory - Time to Achieve Hb Increase of >1.0 g/dL From Baseline Visit, Baseline; up to Week 52|Exploratory - Mean Change in Hb Between Baseline (Mean Pretreatment Hb) and the Primary Evaluation Period (Mean Hb From Weeks 24 to 36) Stratified by Pre-baseline Erythropoiesis-stimulating Agent (ESA) Exposure, Baseline; Weeks 24 to 36|Exploratory - Mean Monthly Dose of Intravenous (IV) Elemental Iron Administered in Participants Who Have Received IV Iron, Up to Week 52|Exploratory - Proportion of Participants Receiving IV Iron Therapy, Up to Week 52|Exploratory - Proportion of Participants Receiving Red Blood Cells (RBCs) Transfusion(s), Up to Week 52 |
| Sponsor/Collaborators: | Sponsor: Akebia Therapeutics |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 369 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2016-07 |
| Completion Date: | 2020-03-30 |
| Results First Posted: | 2022-07-18 |
| Last Update Posted: | 2022-07-18 |
| Locations: | Research Site, Huntsville, Alabama, 35805, United States|Research Site, Mesa, Arizona, 85210, United States|Research Site, Anaheim, California, 92801, United States|Research Site, Canyon Country, California, 91387, United States|Research Site, Downey, California, 90240, United States|Research Site, Glendale, California, 91204, United States|Research Site, Granada Hills, California, 91344, United States|Research Site, La Mesa, California, 91942, United States|Research Site, Long Beach, California, 92886, United States|Research Site, Los Angeles, California, 90022, United States|Research Site, Montebello, California, 90640, United States|Research Site, Monterey Park, California, 91754, United States|Research Site, Newhall, California, 91321, United States|Research Site #1, Northridge, California, 91324, United States|Research Site #2, Northridge, California, 91324, United States|Research Site, Riverside, California, 92503, United States|Research Site, Riverside, California, 92505, United States|Research Site, Sacramento, California, 95825, United States|Research Site, San Diego, California, 92115, United States|Research Site, San Dimas, California, 91773, United States|Research Site, Whittier, California, 90603, United States|Research Site, Arvada, Colorado, 80002, United States|Research Site, Westminster, Colorado, 80031, United States|Research Site, Stamford, Connecticut, 06902, United States|Research Site, Coral Gables, Florida, 33134, United States|Research Site, Coral Springs, Florida, 33071, United States|Research Site, Lauderdale Lakes, Florida, 33313, United States|Research Site, Miami Beach, Florida, 33140, United States|Research Site, Miami, Florida, 33125, United States|Research Site, Miami, Florida, 33150, United States|Research Site, Winter Park, Florida, 32789, United States|Research Site, Augusta, Georgia, 30904, United States|Research Site, Columbus, Georgia, 31904, United States|Research Site #2, Lawrenceville, Georgia, 30046, United States|Research Site, Statesboro, Georgia, 30458, United States|Research Site, Meridian, Idaho, 83642, United States|Research Site, Takoma Park, Maryland, 20912, United States|Research Site, Roseville, Michigan, 48066, United States|Research Site, Kansas City, Missouri, 64111, United States|Research Site, Albuquerque, New Mexico, 87109, United States|Research Site, Astoria, New York, 11102, United States|Research Site, Winston-Salem, North Carolina, 27103, United States|Research Site, Philadelphia, Pennsylvania, 19106, United States|Research Site #1, Chattanooga, Tennessee, 37408, United States|Research Site #2, Chattanooga, Tennessee, 37408, United States|Research Site, Knoxville, Tennessee, 37923, United States|Research Site, Nashville, Tennessee, 37205, United States|Research Site, Arlington, Texas, 76015, United States|Research Site, El Paso, Texas, 79935, United States|Research Site, Houston, Texas, 77054, United States|Research Site, Houston, Texas, 77099, United States|Research Site, San Antonio, Texas, 78212-4740, United States|Research Site, San Antonio, Texas, 78229, United States|Research Site, Hampton, Virginia, 23666, United States|Research Site, Bahia Blanca, Buenos Aires, B8001HXM, Argentina|Research Site, Ciudad Autonoma Buenos Aires, Buenos Aires, C1181ACH, Argentina|Research Site, Junin, Buenos Aires, 6000, Argentina|Research Site, Pergamino, Buenos Aires, B2700CPM, Argentina|Research Site, Temperley, Buenos Aires, 1834, Argentina|Research Site, Cordoba, 5000, Argentina|Research Site, Corrientes, 3400, Argentina|Research Site, Salta, A4400AXO, Argentina|Research Site, San Luis, 5700, Argentina|Research Site, Fortaleza, Ceará, 60430-370, Brazil|Research Site, Belo Horizonte, Minas Gerais, 30150-221, Brazil|Research Site, Juiz de Fora, Minas Gerais, 36036-330, Brazil|Research Site, Curitiba, Paraná, 80010-030, Brazil|Research Site, Maringá, Paraná, 87060-040, Brazil|Research Site, Canoas, Rio Grande Do Sul, 92425-900, Brazil|Research Site, Passo Fundo, Rio Grande Do Sul, 99010-080, Brazil|Research Site, Porto Alegre, Rio Grande Do Sul, 90035-074, Brazil|Research Site, Porto Alegre, Rio Grande Do Sul, 90035-903, Brazil|Research Site, Joinville, Santa Catarina, 89202-050, Brazil|Research Site, Santo André, Sao Paulo, 09090-790, Brazil|Research Site, São Bernardo do Campo, Sao Paulo, 09715-090, Brazil|Research Site, São Paulo, Sao Paulo, 04039-000, Brazil|Research Site, Villingen-Schwenningen, Baden Wuerttemberg, 78054, Germany|Research Site, Rostock, Mecklenburg Vorpommern, 18057, Germany|Research Site, Duesseldorf, Nordrhein Westfalen, 40210, Germany|Research Site, San Giovanni Rotondo, Foggia, 71013, Italy|Research Site, Genova, 16132, Italy|Research Site, Lecco, 23900, Italy|Research Site, Napoli, 80138, Italy|Research Site, Pavia, 27100, Italy|Research Site, Roma, 168, Italy|Research Site, Siena, 53100, Italy|Research Site, Chuncheon, Gangwon-do, 200-702, Korea, Republic of|Research Site, Seongnam-si,, Gyeonggi-do, 13496, Korea, Republic of|Research Site, Busan, 47392, Korea, Republic of|Research Site, Seoul, 6591, Korea, Republic of|Research Site, Seoul, 7345, Korea, Republic of|Research Site, Zapopan, Jalisco, 45030, Mexico|Research Site, Morelia, Michoacán, 58260, Mexico|Research Site, Culiacan, Sinaloa, 80230, Mexico|Research Site, Golub Dobrzyn, 87-400, Poland|Research Site, Lodz, 90-153, Poland|Research Site, Lodz, 92-213, Poland|Research Site, Leiria, 2400-441, Portugal|Research Site, Loures, 2674-514, Portugal|Research Site #2, Kemerovo, 650066, Russian Federation|Research Site, Krasnoyarsk, 660022, Russian Federation|Research Site, Moscow, 125466, Russian Federation|Research Site, Saint-Petersburg, 197022, Russian Federation|Research Site, Saint-Petersburg, 197110, Russian Federation|Research Site, St. Petersburg, 198205, Russian Federation|Research Site, St. Petersburg, 199004, Russian Federation|Research Site, Brovary, 7400, Ukraine|Research Site, Cherkassy, 18009, Ukraine|Research Site, Dnipro, 49005, Ukraine|Research Site, Ivano-Frankivsk, 76008, Ukraine|Research Site, Kharkiv, 61037, Ukraine|Research Site, Kyiv, 2125, Ukraine|Research Site, Mykolaiv, 54058, Ukraine|Research Site, Ternopil, 46002, Ukraine|Research Site, Uzhgorod, 88018, Ukraine|Research Site, Vinnytsia, 21018, Ukraine|Research Site, Zaporizhzhia, 69600, Ukraine|Research Site, Zhytomyr, 10002, Ukraine |
| URL: | https://clinicaltrials.gov/show/NCT02865850 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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