{"id":"W4362523215","doi":"10.1136/bmjopen-2022-065613","title":"Study protocol of a randomised, double-blind, placebo-controlled, two-arm parallel-group, multi-centre phase 3 pivotal trial to investigate the efficacy and safety of recombinant human alkaline phosphatase for treatment of patients with sepsis-associated acute kidney injury","year":2023,"lang":"en","type":"article","venue":"BMJ Open","topic":"Alkaline Phosphatase Research Studies","field":"Medicine","cited_by":17,"is_retracted":false,"has_abstract":true,"ca_institutions":"University of Calgary","funders":"Grifols; Abiomed; Astute Medical; Gilead Sciences; Shionogi; Sanofi; Fresenius Medical Care North America; AstraZeneca; Pfizer; Amgen","keywords":"Medicine; Placebo; Interim analysis; Tolerability; Clinical trial; Internal medicine; Acute kidney injury; Sepsis; Randomized controlled trial; Data monitoring committee; Kidney disease; Renal function; Adverse effect; Surgery; Pathology; Alternative medicine","routes":{"ca_aff":true,"ca_fund":false,"ca_venue":false,"about_ca":false,"invisible_to_affiliation_only":false},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.02001515,0.006263013,0.009528627,0.001173663,0.003160988,0.003032519,0.003891668,0.007336656,0.07756725],"category_scores_gemma":[0.01778346,0.002497831,0.003398437,0.00191233,0.00334968,0.003060143,0.001665339,0.008210912,0.01986308],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.002951986,"about_ca_system_score_gemma":0.01472655,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.00113932,"about_ca_topic_score_gemma":0.002824,"domain_scores_codex":[0.9872352,0.007419942,0.00111203,0.0019271,0.00128725,0.001018393],"domain_scores_gemma":[0.9909521,0.001786949,0.001423066,0.001223583,0.001916513,0.00269765],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"randomized_trial","study_design_gemma":"randomized_trial","study_design_scores_codex":[0.9235246,0.008574441,0.0007282026,0.01134836,0.001214191,0.0002151842,0.0002409025,0.0009243972,0.002132981,0.004017959,0.0188005,0.02827838],"study_design_scores_gemma":[0.9279844,0.02440541,0.001126973,0.001255126,0.0007006703,0.00007896766,0.00004944659,0.001014214,0.0003922092,0.001851665,0.04105862,0.00008227587],"study_design_candidate":"randomized_trial","study_design_consensus":"randomized_trial","genre_codex":"protocol","genre_gemma":"protocol","genre_scores_codex":[0.005021151,0.001006009,0.00376882,0.0005717952,0.001441937,0.9811878,0.003998306,0.0001581037,0.002846126],"genre_scores_gemma":[0.009379828,0.0005245619,0.004141241,0.0008983063,0.0003647136,0.9817502,0.001262529,0.00001966615,0.001658907],"genre_candidate":"protocol","genre_consensus":"protocol","teacher_disagreement_score":0.07756725,"threshold_uncertainty_score":0.2594883,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.1180421893430407,"score_gpt":0.4735775338146222,"score_spread":0.3555353444715815,"validation_status":"score_only:v0-immature-baseline","note":"Baseline scores from an immature model (maturity gate not passed). Scores rank; they never assert a category."}}