| Vanrafia (atrasentan) / Novartis |
NCT01424319: Reducing Residual Albuminuria in Subjects With Diabetes and Nephropathy With Atrasentan |
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| Completed | 2b | 58 | Japan | Atrasentan low dose group, Atrasentan high dose group, Atrasentan placebo group | AbbVie (prior sponsor, Abbott) | Chronic Kidney Disease, Diabetic Nephropathy | 07/12 | 07/12 | | |
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NCT01356849: Evaluate the Efficacy and Safety of Once Daily Administration of Atrasentan Tablets (Low and High) Compared to Placebo in Reducing Residual Albuminuria in Type 2 Diabetic Patients With Nephropathy Who Are Treated With the Maximum Tolerated Labeled Dose of a Renin Angiotensin System (RAS) Inhibitor |
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| Completed | 2b | 149 | US, Canada, RoW | Atrasentan, ABT-627, Placebo | AbbVie (prior sponsor, Abbott) | Chronic Kidney Disease, Diabetic Nephropathy | 08/12 | 08/12 | | |
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NCT01399580: A Prospective, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Efficacy and Safety of Atrasentan, Including Thoracic Bioimpedance, in Type 2 Diabetic Subjects With Nephropathy |
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| Completed | 2b | 48 | US | Atrasentan, ABT-627, Placebo | AbbVie (prior sponsor, Abbott) | Chronic Kidney Disease, Diabetic Nephropathy | 09/12 | 09/12 | | |
NCT00920764: A Study of Atrasentan on Reducing Albuminuria in Type 2 Diabetic Nephropathy Treated With Renin-Angiotensin System Inhibitors |
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| Completed | 2a | 92 | US | Placebo for Atrasentan 0.2 mg/mL solution, 0.25 mg Atrasentan QD, 0.75 mg Atrasentan QD, 1.75 mg Atrasentan QD | AbbVie (prior sponsor, Abbott) | Chronic Kidney Disease, Diabetic Nephropathy | 04/10 | 05/10 | | |
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NCT00039429: Atrasentan in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer |
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| Completed | 2 | 180 | US | atrasentan hydrochloride | Eastern Cooperative Oncology Group, National Cancer Institute (NCI) | Kidney Cancer | 04/06 | | | |
NCT00038662: Safety and Efficacy of Atrasentan in Men With Hormone Naive Prostate Cancer Exhibiting Early Signs of Biochemical Failure |
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| Completed | 2 | 200 | US, Canada | Atrasentan | Abbott | Prostatic Neoplasms | | | | |
NCT00181558: Atrasentan and Zometa for Men With Prostate Cancer Metastatic to Bone |
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| Completed | 2 | 44 | US | Atrasentan, Zoledronic Acid (Zometa) | Massachusetts General Hospital, Dana-Farber Cancer Institute, Brigham and Women's Hospital, Abbott | Prostate Cancer, Adenocarcinoma of the Prostate | 12/06 | 12/06 | | |
NCT00653328: Ph II Atrasentan + DOXIL in Recurrent Ovarian/Fallopian/Peritoneal Serous Papillary Adenocarcinoma |
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| Terminated | 2 | 15 | US | atrasentan hydrochloride, ABT-627, Xinlay, doxil, pegylated liposomal doxorubicin hydrochloride (Doxil) | Vanderbilt-Ingram Cancer Center, National Cancer Institute (NCI) | Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer | 03/09 | 03/09 | | |
| Completed | 2 | 20 | US, Europe | Atrasentan | AbbVie | Nephropathy, Diabetes | 04/18 | 07/18 | | |
2020-004176-18: A Phase 2, Open-Label, Basket Study of Atrasentan in Patients with Proteinuric Glomerular Diseases (The AFFINITY Study) Estudio de fase 2, abierto, “en cesta”, de atrasentán en pacientes con enfermedades glomerulares proteinúricas (estudio AFFINITY) |
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| Ongoing | 2 | 80 | Europe | atrasentan, [atrasentan], Film-coated tablet | Chinook Therapeutics U.S., Inc., CHINOOK THERAPEUTICS, U.S., Inc, Chinook Therapeutics U.S., Inc. | Proteinuric glomerular diseases, including:Immunoglobulin A nephropathy (IgAN) (with UPCR 0.5 to <1.0 g/g)Focal segmental glomerulosclerosis (FSGS)Alport SyndromeDiabetes kidney disease (DKD) (as add-on to RAS and sodium glucose co-transporter 2 [SGLT2] inhibitors) Enfermedades glomerulares proteinúricas, que incluyen:Nefropatía por inmunoglobulina A (NIgA) (con UPCR de 0,5 a <1,0 g / g)Glomeruloesclerosis focal y segmentaria (GEFS)Síndrome de AlportNefropatía diabética (ND) (como complemento de los inhibidores del cotransportador 2 [SGLT2] de glucosa y sodio RAS), Proteinuric glomerular diseases:Immunoglobulin A nephropathy (IgAN) Focal segmental glomerulosclerosis (FSGS)Alport SyndromeDiabetes kidney disease (DKD) Enfermedades glomerulares proteinúricas:Nefropatía por inmunoglobulina A (NIgA)Glomeruloesclerosis focal y segmentaria (GEFS)Síndrome de AlportNefropatía diabética (ND), Diseases [C] - Immune System Diseases [C20] | | | | |
ASSIST, NCT06841094: Randomized, Double-blind, Placebo-controlled, Crossover Study of Atrasentan in Subjects With IgA Nephropathy |
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| Active, not recruiting | 2 | 54 | Europe, US, RoW | Atrasentan, CHK-01, Atrasentan Hydrochloride, ABT-627, Placebo | Novartis Pharmaceuticals | IgA Nephropathy, Immunoglobulin A Nephropathy | 10/25 | 08/26 | | |
| Active, not recruiting | 2 | 103 | Europe, US, RoW | Atrasentan, CHK-01, Atrasentan Hydrochloride, ABT-627 | Novartis Pharmaceuticals | IgA Nephropathy, Focal Segmental Glomerulosclerosis, Alport Syndrome, Diabetic Kidney Disease, Diabetic Nephropathy Type 2, Immunoglobulin A Nephropathy | 07/24 | 10/26 | | |
| Completed | 2 | 54 | Europe, US, RoW | Atrasentan, CHK-01, Atrasentan Hydrochloride, ABT-627, Placebo | Novartis Pharmaceuticals, Novartis Pharma AG | IgA Nephropathy, Immunoglobulin A Nephropathy | 06/25 | 10/25 | | |
ASSIST, 2023-503828-13-00: A study to learn if atrasentan is safe and works in people with IgA nephropathy who are taking an SGLT2i |
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| Completed | 1/2 | 10 | Europe | Matching placebo film-coated round tablets, atrasentan, DAPAGLIFLOZIN
| Novartis Pharma AG, Novartis Pharma AG | Nephrology | | | | |
