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Clinical Trial Details

Trial ID: L2081
Source ID: NCT04573920
Associated Drug: Atrasentan
Title: Atrasentan in Patients With Proteinuric Glomerular Diseases
Acronym: AFFINITY
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: IgA Nephropathy|Focal Segmental Glomerulosclerosis|Alport Syndrome|Diabetic Kidney Disease|Diabetic Nephropathy Type 2|Immunoglobulin A Nephropathy
Interventions: DRUG: Atrasentan
Outcome Measures: Primary: Change in proteinuria for IgAN, FSGS, and Alport syndrome patients receiving 0.75 mg atrasentan QD, The change in urine protein:creatinine ratio (UPCR) from baseline to Week 12, Up to Week 12 or approximately 3 months|Change in albuminuria for DKD patients, The change in urine albumin:creatinine ratio (UACR) from baseline to Week 12, Up to Week 12 or approximately 3 months|Change in proteinuria for FSGS patients at 1.5 mg dose, The change in urine protein:creatinine ratio (UPCR) from baseline to Week 24, Up to Week 24 or approximately 6 months|Change in proteinuria for FSGS patients at 1.5 mg dose, The change in urine protein:creatinine ratio (UPCR) from baseline to Week 30, Up to Week 30 or approximately 7.5 months |
Sponsor/Collaborators: Sponsor: Novartis Pharmaceuticals
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 103
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-04-06
Completion Date: 2026-07-28
Results First Posted:
Last Update Posted: 2025-01-30
Locations: Apoge e Clinical Research, LLC, Huntsville, Alabama, 35805, United States|Kidney Disease Medical Group, Glendale, California, 91204, United States|Academic Medical Research Institute, Los Angeles, California, 90022, United States|North America Research Institute, San Dimas, California, 91773, United States|Stanford University, Stanford, California, 94305, United States|Colorado Kidney Care, P.C., Denver, Colorado, 80230, United States|Elixia Tampa, LLC, Temple Terrace, Florida, 33637, United States|Fides Clinical Research - North Atlanta Kidney Specialist, Atlanta, Georgia, 30342, United States|NANI Research, LLC, Hinsdale, Illinois, 60521, United States|Northwest Louisiana Nephrology, Shreveport, Louisiana, 71101, United States|Tufts Medical Center, Boston, Massachusetts, 02111, United States|University of Minnesota Health Clinical Research Unit- A UMPhysicians Clinic, Minneapolis, Minnesota, 55455, United States|DaVita Clinical Research, Las Vegas, Nevada, 89128, United States|Mountain Kidney and Hypertension Associates, Asheville, North Carolina, 28801, United States|Brookview Hills Research Associates, LLC, Winston-Salem, North Carolina, 27103, United States|Renal Disease Research Institute, LLC, Dallas, Texas, 75246, United States|Prolato Clinical Research Center, Houston, Texas, 77054, United States|San Antonio Kidney Disease Center Physicians Group, P.L.L.C, San Antonio, Texas, 78258, United States|Renal Research, Gosford, New South Wales, 2250, Australia|Royal North Shore Hospital, St. Leonards, New South Wales, 2065, Australia|Royal Brisbane and Women's Hospital, Herston, Queensland, 4029, Australia|Monash Health- Monash Medical Centre, Clayton, Victoria, 3168, Australia|Melbourne Renal Research Group, Reservoir, Victoria, 3073, Australia|Sunshine Hospital, St Albans, Victoria, 3021, Australia|Ospedale Pediatrico Bambino Gesu, Rome, Lazio, 00165, Italy|Fondazione Salvatore Maugeri IRCCS, Pavia, Lombardy, 27100, Italy|SoonChunHyang University Hospital Cheonan, Cheonan-si, Chungcheongnam-do, 31151, Korea, Republic of|Kyung Hee University Hospital at Gangdong, Gangdong, Korea, Republic of|Hallym University Sacred Heart Hospital, Gyeonggi-do, 14068, Korea, Republic of|Korea University Anam Hospital, Seoul, 02841, Korea, Republic of|Severance Hospital, Yonsei University, Seoul, 3722, Korea, Republic of|Hospital Ribera Polusa, Lugo, Galicia, 27004, Spain|Hospital Universitario Puerta del Hierro Majadahonda, Majadahonda, Madrid, 28222, Spain|Hospital de Sagunto, Sagunto, Valencia, 46520, Spain|Hospital Universitari Vall d'Hebron, Barcelona, 08035, Spain|Hospital General Universitario Gregorio Maranon, Madrid, 28007, Spain|Royal Hospital London, London, England, United Kingdom|Sheffield Teaching Hospitals NHS, Sheffield, S5 7AU, United Kingdom
URL: https://clinicaltrials.gov/show/NCT04573920

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D440 Atrasentan small molecule DB06199 Details